Opinion | What if Covid Were 10 Times Deadlier? – The New York Times

Opinion | What if Covid Were 10 Times Deadlier? – The New York Times

COVID-19 vaccines – Harvard Health

COVID-19 vaccines – Harvard Health

September 17, 2021

What you need to know before getting vaccinated

The FDA has granted full approval to one COVID-19 vaccine and has authorized two others. As more people get their shots and more time passes, we will learn how long protection lasts. And we will gain answers to important questions, including whether vaccinations protect against emerging variants. The vaccines offer hope for an end to this pandemic.

In August 2021, the FDA granted full approval to the mRNA COVID-19 vaccine developed by Pfizer and BioNTech. This vaccine had received emergency use authorization (EUA) in December 2020. The mRNA COVID-19 vaccine developed by Moderna also received EUA in December 2020. The Johnson & Johnson adenovirus vaccine was granted EUA by the FDA in late February 2021. Use of the Johnson & Johnson vaccine resumed on April 23, 2021, after a temporary pause.

In August 2021, the FDA granted full approval to the Pfizer/BioNTech COVID-19 mRNA vaccine for use in people ages 16 years and older. The transition from emergency use authorization (EUA) status to full licensure was based on additional data and longer follow-up showing that the vaccine met certain safety, effectiveness, and manufacturing quality standards. The Pfizer/BioNTech vaccine can now be marketed under the brand name Comirnaty.

In granting full approval, the FDA analyzed data from 44,000 study participants. Half received two doses of the Pfizer/BioNTech vaccine and the other half received the placebo. Over six months of follow-up, the vaccine was 91.1% effective at preventing symptomatic COVID-19 infection.

A subset of study participants was followed for six months to look at safety outcomes associated with the vaccine. A small but increased risk of two inflammatory heart conditions, myocarditis and pericarditis, was identified and will be noted in the FDAs prescribing information. The risk is higher in males under age 40, and highest in males ages 12 to 17. Safety data will continue to be collected and monitored.

Before granting full approval, the FDA also inspected vaccine manufacturing facilities to ensure vaccine quality. Full approval gives doctors some leeway to prescribe the vaccine for "off-label use."

In the US, more than 92 million people have been fully vaccinated with the Pfizer/BioNTech vaccine since it received EUA in December 2020. Children ages 12 to 15 years will continue to use the vaccine under EUA status.

EUA status may be granted by the FDA during public health emergencies when they determine that the known and potential benefits of a medical product in this case, the COVID-19 vaccine outweigh the known and potential risks.

On May 10, 2021, the FDA expanded its emergency use authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine to include adolescents 12 to 15 years old. Previously, the Pfizer vaccine was authorized for use in children 16 years and older. For now, this is the only vaccine authorized in the U.S. for anyone under age 18.

Pfizer has been conducting age de-escalation studies, in which its vaccine is tested in groups of children of descending age. The EUAs expanded authorization was based on results from a Phase 3 trial of children ages 12 to 15. The trial enrolled 2,260 adolescents; half received the Pfizer mRNA vaccine, the other received a saltwater placebo.

The immune response in the vaccinated adolescent group was even stronger than that in vaccinated 16- to 25-year-olds enrolled in an earlier study. In addition, a total of 16 symptomatic cases of COVID-19 were reported during the trial, all in the placebo group, which meant that the vaccine had been 100% effective in preventing COVID-19.

Vaccine-related side effects were mild and included pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain. Pfizer has also started testing the vaccine in children younger than 12 years.

Being fully vaccinated with a COVID-19 vaccine does reduce the risk of long COVID. Also called post-COVID-19 syndrome or post-acute sequelae of SARS-CoV-2 infection (PASC), long COVID is the term for symptoms that arise or persist more than 28 days after an initial COVID-19 infection.

Vaccination may reduce the risk of long COVID in two ways. The first is by reducing the risk of becoming infected with COVID in the first place. But what about people who experience breakthrough infections, becoming infected despite being vaccinated?

A study published in The Lancet shows that fully vaccinated people who experience breakthrough infections are about 50% less likely to develop long COVID than people who are infected without having been vaccinated. These results are based on self-reported data submitted via the COVID Symptom Study phone app in the United Kingdom between December 2020 and July 2021.

Minor side effects are common after COVID-19 vaccination. Almost everyone experiences arm pain at the injection site. Other symptoms can include low grade fever, body ache, chills, fatigue, and headache.

You can expect to feel better within 24 to 48 hours. Some people feel too unwell to go to work or perform their usually daily activities during this period. Contact your doctor if your symptoms have not improved by the third day.

Moving your sore arm around may help to relieve discomfort. If you have a fever, drink plenty of fluids. Over the counter pain relievers like ibuprofen or acetaminophen can also help with fever, pain, and other discomfort. However, its best to not take a pain reliever right before getting your shot, because there is a chance this could blunt your immune response.

The good news: These side effects are a sign that the vaccine is working and that your body is building an antibody response. The currently available vaccines require two shots, and side effects are more likely to occur after the second shot.

There have been rare cases of people having a severe allergic reaction after receiving the mRNA COVID-19 vaccine. As a result, everyone getting an mRNA vaccine in the US must be observed for at least 15 minutes after getting their shot, so they can receive immediate medical treatment if they experience a severe allergic reaction.

Despite the small risk, most people with a history of severe allergy can safely get the mRNA COVID-19 vaccine. This includes people who are allergic to food, pollen, bee stings, and medications taken by mouth. If you have a history of severe allergy, tell the person administering your vaccine. You will be observed for at least 30 minutes, instead of the usual 15 minutes.

If you have a history of allergic reactions to injectable medications or other vaccines, the CDC recommends asking your doctor if you should get one of the currently available mRNA vaccines.

There are some people who should not get an mRNA COVID vaccine. You should not get one if you are allergic to any components of the mRNA vaccine, which include polyethylene glycol (PEG) and polysorbate. And you should not get the second dose of an mRNA vaccine if you had an allergic reaction within the first 30 minutes after receiving the first vaccine dose.

If you have questions regarding the safety of the COVID vaccine for you, your best option is to talk to your doctor.

There are only a few groups of people who should not get the mRNA vaccine. They include people who

If you have a history of allergic reactions to other (non-COVID) vaccines or to injectable medications, ask your doctor if it is safe for you to get one of the currently available mRNA vaccines.

Finally, it is possible that convalescent plasma or monoclonal antibodies, both of which are used to treat COVID-19, could reduce the effectiveness of the vaccine. If you have received either of these treatments, wait 90 days before getting your vaccine.

The Delta variant is different from previous SARS-CoV-2 variants that have made their way to the US. Its highly contagious and may cause more severe disease. It is also more likely than previous variants to be spread by vaccinated people experiencing breakthrough infections.

Evidence presented to the CDC showed the Delta variant to be much more contagious than previous variants, with a risk of transmission similar to chickenpox. It also appears that people who are infected can spread the virus for longer periods of time.

In addition, people who are vaccinated and then get infected (breakthrough infections) can also spread the virus to others, perhaps to the same extent as those who are unvaccinated. This is also new; vaccinated people were much less likely to spread previous variants.

Finally, international studies point to the Delta variant being more likely to cause severe disease.

The good news is that while vaccination may be less effective at preventing infection and spread of the Delta variant, it is still highly protective against severe disease, hospitalization, and death. Get the COVID-19 vaccine if you have not already done so.

In July 2021, the CDC advised all people vaccinated and unvaccinated to wear masks in public indoor places, in areas of the country with substantial or high transmission of the virus. Given the threat posed by the Delta variant, its reasonable for everyone to start wearing a mask in indoor public spaces, regardless of the level of virus in your area.

Masks reduce the amount of virus we breathe in, and breathe out. Combined with the vaccine, masks provide a one-two punch that reduces the risk of spread to children who are not yet eligible for vaccines, to people with weakened immune systems, and to others who are unvaccinated. Masks also provide additional protection for the wearer, including who are fully vaccinated.

Three studies released by the CDC in August 2021 suggest that the COVID-19 mRNA vaccines (Pfizer/BioNTech and Moderna) become less effective over time. The studies, all published in MMWR, show that vaccine protection against mild to moderate infection begins to drop beginning several months after the second dose. However, the vaccines continue to be highly protective against severe illness, hospitalization, and death.

The increase in mild and moderate breakthrough infections may not be entirely due to a decrease in the immunity provided by the vaccines. Its possible the vaccines are not as effective against the Delta variant as they were against previous variants. And safety precautions such as mask wearing and physical distancing have also decreased in the past several months. All these factors may play into increased breakthrough infections in fully vaccinated people.

The MMWR studies did not address the effectiveness of the Johnson & Johnson vaccine over time.

A breakthrough infection is one that occurs after full vaccination.

In an article published in MMWR, the CDC reported 10,262 breakthrough infections through the end of April 2021. By that point, more than 100 million Americans had received the COVID-19 vaccine.

The vast majority of breakthrough infections were asymptomatic, mild, or moderate. About 1,000 people with breakthrough infections were hospitalized, and 160 died, though the hospitalizations and deaths were not always related to COVID-19.

These numbers tell us that the vaccines are doing a good job preventing infection and severe illness. None of the vaccines were 100% effective in clinical trials, so a small number of breakthrough infections was expected.

In August 2021, the FDA authorized a third dose of an mRNA vaccine (Pfizer/BioNTech or Moderna) for certain people who are immunocompromised. The third dose should be given at least 28 days after the second dose.

The COVID-19 vaccines, like other vaccines, work by stimulating a persons immune system to produce antibodies against the virus. If the antibodies later encounter the actual virus, they are ready to recognize and destroy it.

A person with a weakened immune system may not be able to produce a strong enough immune response to the standard, two-dose COVID mRNA vaccine regimen. This leaves them more likely to have a breakthrough infection, and increases the risk of more severe disease if they do become infected. A third vaccine dose may enhance the immune response in some people who are immunocompromised.

The FDA authorized a third dose for people who are moderately to severely immunocompromised. A person may have a weakened immune system for a variety of reasons. These include being born with an immunodeficiency, having advanced or untreated HIV, and having a chronic medical condition such as chronic kidney disease or lack of a spleen. Many types of medication also suppress the immune response, including some cancer treatments, TNF blockers, some biologic agents, and high-dose corticosteroids. Talk to your doctor if you think you may qualify for a third COVID vaccine dose.

The FDA and CDC further recommend that anyone with a weakened immune system should continue to wear masks, stay six feet apart from others, and avoid crowds and poorly ventilated indoor spaces.

In July 2021, the FDA warned that the Johnson & Johnson (J&J) COVID-19 vaccine may lead to a small but increased risk of Guillain-Barr syndrome (GBS). GBS is a disorder in which the body destroys its own nerve cells. It can lead to muscle weakness and sometimes paralysis, trouble breathing, or, rarely, death. The risk of developing GBS after receiving the J&J vaccine is very low, and benefits of vaccination still far outweigh the risks.

The FDAs warning was based on preliminary reports of about 100 cases of GBS that occurred in people who had received the J&J vaccine. To date, about 12.8 million people in the US have gotten the J&J vaccine. Most of the reported cases occurred in men ages 50 years and older, about two weeks after vaccination.

Almost all required hospitalization because GBS can affect the nerves to chest muscles and the diaphragm, making it difficult to breathe. Most people recover completely from GBS within a few months, but some never regain full strength.

Seek immediate medical attention if you experience any of the following symptoms after receiving the J&J COVID-19 vaccine:

On April 13, 2021, the FDA and CDC jointly recommended pausing use of the Johnson & Johnson COVID-19 vaccine until the agencies could review the cases of a rare but serious type of blood clot that were reported in six women who received the Johnson & Johnson vaccine. On April 23, the FDA and CDC recommended lifting the pause, and allowing use of the vaccine to resume. They made this decision after their medical and scientific teams examined the data and determined that the vaccines known and potential benefits outweigh its known and potential risks.

The Johnson & Johnson vaccine is once again available for use in the US, for anyone ages 18 and older. However, the vaccines label and factsheet will now warn of the rare risk of developing blood clots involving blood vessels in the brain, abdomen, and legs, along with low levels of blood platelets. (This combination is being referred to as thrombosis and thrombocytopenia syndrome, or TTS, an abbreviation of the medical terms for the two conditions.) The label and factsheet also list symptoms of TTS and urge anyone who experiences them after receiving the Johnson & Johnson vaccine to seek immediate medical attention.

Since the FDA granted emergency use authorization (EUA) for the Johnson & Johnson vaccine in late February, more than 8 million doses of the one-dose vaccine have been given. A total of 15 cases of TTS were reported through April 23rd; all occurred in women between the ages of 18 and 59, between six and 15 days after vaccination.

While the risk of experiencing a blood clot after vaccination is very low, anyone who experiences the following symptoms within three weeks of receiving the Johnson & Johnson vaccine should contact their doctor and seek immediate medical care:

The clotting issue reported with the Johnson & Johnson vaccine is similar to the rare cases of unusual blood clots that the European Medicines Agency linked to the AstraZeneca vaccine.

In a study published in MMWR in September 2021, the CDC reported that even after Delta became the dominant COVID variant in the US, full vaccination has effectively prevented against COVID hospitalizations and deaths. The study looked at more than 600,000 cases of COVID in 13 locations across the US between April and July 2021. Compared to people who were not vaccinated, those who were fully vaccinated were five times less likely to become infected, 10 times less likely to be hospitalized, and 11 times less likely to die of COVID. The effectiveness of vaccine protection against infection fell after Delta became the dominant variant in the US. But vaccination continued to effectively protect against COVID-related hospitalization and death.

In an earlier MMWR study published in April 2021, the CDC reported that people who had received both doses of either mRNA vaccine (Pfizer/BioNTech or Moderna) were 90% less likely to get infected with COVID-19 than people who were not vaccinated. In clinical trials, the vaccines were 95% (Pfizer/BioNTech) and 94.1% (Moderna) effective. Several viral variants were circulating during this study period, but the April study preceded the rise of the Delta variant in the US.

Two reports published in MMWR in September 2021 found that vaccine protection has declined in older adults. However, vaccinated older adults still enjoy significant protection compared to older adults who are unvaccinated.

One report describes the results of a study looking at the effectiveness of the COVID vaccines (Pfizer/BioNTech, Moderna, and Johnson & Johnson) in preventing COVID-related hospitalization at five Veterans Affairs Medical Centers in the US. It found that vaccines were 80% effective in preventing COVID-related hospitalization in people aged 66 years and older compared to 95% in people aged 18 to 65 years.

The second report is an interim analysis of ongoing data collection from medical sites in nine different states. The vaccines were found to be 89% effective at preventing COVID-related hospitalization in people ages 18 to 74 and 76% in people aged 75 or older. The researchers based their findings on an analysis of 32,867 medical encounters, including visits to hospitals, emergency departments, and urgent care sites. The data collection occurred during a time when Delta was responsible for more than half of infections.

A small study conducted earlier this year by the CDC and published inMMWRreported that the two mRNA vaccines (Pfizer/BioNTech and Moderna) had been as effective in older adults in the real world as they were in the clinical trials that led to authorization of their use. That study found that full vaccination reduced risk of COVID-related hospitalization by 94% compared to 95% (Pfizer/BioNTech) and 94.1% (Moderna) in the clinical trials. At the time of this study, the Delta variant was much less common.

This newest data does suggest that Delta variant is the primary reason for the decline in vaccine effectiveness. But the numbers still strongly support vaccine efficacy even during a period of Delta dominance.

Its natural to want to make an informed decision about the COVID-19 vaccine. Fortunately, the safety of the vaccine seen in the clinical trials has been verified by the real-world results. And in August 2021, the FDA granted full approval to the Pfizer/BioNTech COVID-19 mRNA vaccine for use in people ages 16 years and older. The transition from emergency use authorization (EUA) status to full licensure was based on additional data and longer follow-up showing that the vaccine met certain safety, effectiveness, and manufacturing quality standards.

Warp speed? Yes, the speed with which the COVID-19 vaccines were developed was incredibly fast. But the science and technology to make it happen came after decades of research.

COVID-19 mRNA vaccines are new, but scientists have been studying mRNA for many years. They cannot change your DNA. The mRNA sends a message to the bodys cells to make only a specific protein, not a virus, that stimulates the immune system to give you protection. Experts predict that most vaccines in the future will use mRNA technology.

If you still have doubts about the vaccine, we recommend this short video produced by the Black Womens Health Imperative.

Some communities, particularly communities of color, may have historical reasons to doubt the health care system. But these communities have also been among the hardest hit by this pandemic, and like all of us, have a lot to gain from vaccination.

The Black Womens Health Imperative is a national organization dedicated to improving the health and wellness of Black women and girls.

Fully vaccinated people can participate in most indoor and outdoor activities without a mask and without physical distancing. In July 2021, the CDC advised all people, including those who are fully vaccinated, to wear masks in public indoor places in areas of the country with substantial or high transmission of the virus.

In addition, youll still need to follow federal, state, tribal, and local laws, and workplace or business requirements around mask wearing and physical distancing.

For people who are not fully vaccinated, the CDC continues to recommend mask wearing and other preventive measures in some outdoors settings and in most indoor settings.

Mutations have led to several new, concerning coronavirus variants, including the B.1.1.7 (Alpha) variant, which was first detected in the United Kingdom; the B.1.351 (Beta) variant, which originated in South Africa; the P.1 (Gamma) variant, which originated in Brazil, and the B.1.617.2 (Delta) variant, which was first documented in India. Emerging evidence suggests that the current vaccines are effective against at least some of these variants.

Two peer-reviewed and published studies have found the Pfizer/BioNTech vaccine to be extremely effective against the Alpha and the Beta variants. The first study, published inNEJM, looked at data from more than 200,000 people from the country of Qatar between early February and late March 2021. During that time, the Alpha and Beta variants were responsible for nearly all COVID cases in that country. The researchers found that in people who were fully vaccinated, the Pfizer vaccine was 97.4% effective at preventing severe, critical, or fatal disease caused by the Alpha or Beta variants.

The second study, published in TheLancet, looked at more than 200,000 COVID infections in Israel from late January to early April 2021, when the Alpha variant accounted for more than 90% of infections. The researchers found that in fully vaccinated people, the Pfizer vaccine was nearly 97% or more effective at preventing symptomatic COVID-19, COVID-related hospitalization, severe or critical COVID-19, or COVID-related death.

Research has also found vaccination to be effective against severe disease, hospitalization, and death caused by the Delta variant, which is now the dominant variant in the US. A study from Public Health England found that full vaccination with the Pfizer/BioNTech vaccine was 88% effective at protecting against symptomatic illness caused by the Delta variant, and 96% effective at preventing hospitalization due to the Delta variant. However, the vaccines appear to be less effective at preventing all infection (including mild and asymptomatic infection). And the Delta variant is more likely than previous variants to be spread by vaccinated people experiencing breakthrough infections.

Studies on the effectiveness of the Moderna vaccine are ongoing. In the lab, it has performed well against the Alpha variant, compared to the original, unmutated virus. However, it was less effective against the Beta and Delta variants compared to the unmutated virus and the Alpha variant. More study is needed to see if the laboratory results hold up in real-world conditions.

It's important to remember that both the Pfizer/BioNTech and Moderna vaccines are extremely effective 95% and 94.1%, respectively. Even with some possible decrease in effectiveness against variants, they will still provide excellent protection against severe illness.

Another study, published inNature, looked at blood samples from people who received the Johnson & Johnson adenovirus vaccine. It found that the vaccine produced a less robust antibody response against the Beta and Gamma variants compared to the response to the original SARS-CoV-2 virus. However, the T cell immune response held up, particularly among the type of T cells that prevent the virus from spreading within the body. This immune response should protect against developing severe symptoms if a person does get infected. Johnson & Johnson also released data from a small, unpublished laboratory study, which found a strong neutralizing antibody response against the Delta variant in people who had received the single-shot J&J vaccine. The response was sustained for at least eight months, the duration of the study.

On December 18, 2020, the FDA granted emergency use authorization (EUA) to an mRNA COVID-19 vaccine developed by Moderna in collaboration with scientists from the NIH. The vaccine is approved for use in people 18 years and older. This is the second COVID-19 vaccine authorized for use in the US. (The Pfizer/BioNTech vaccine received EUA during the prior week.)

The FDA granted EUA based on their own analysis of efficacy and safety data, as well as on the recommendation made by the Vaccines and Related Biological Products Advisory Committee (VRBPAC). VRBPAC is a group of outside experts in infectious disease, vaccinology, microbiology, immunology, and other related fields.

In briefing documents submitted to the FDA, the Moderna vaccine showed an overall efficacy of 94.1% in preventing COVID-19. This study enrolled 30,400 adults; half received the vaccine, half received a saltwater placebo shot. There were 196 infections among the study participants. Of these, 185 were in the placebo group and 11 were in the vaccine group. All 30 cases of severe COVID occurred in the placebo group, strongly suggesting indicating that the vaccine reduces risk of severe illness.

The vaccine was similarly effective in people older and younger than 65, in men and women, in people with and without medical conditions that put them at high risk for severe illness, and in different racial and ethnic groups.

The most common vaccine side effects were pain at the injection site, fatigue, headache, muscle pain, joint pain, and chills.

This vaccine requires two doses, spaced four weeks apart. In January 2021, the CDC released guidance stating that while the second dose should be administered as close to the recommended four-week interval as possible, it may be scheduled for administration up to six weeks (42 days) after the first dose. We do not yet know how long immunity from this vaccine will last.

In August 2021, the FDA authorized a third dose of mRNA vaccine (Moderna or Pfizer/BioNTech) for certain people with a weakened immune response.

The Moderna vaccine contains synthetic messenger RNA (mRNA), genetic material that enters human cells and instructs them to produce the spike protein found on the surface of the SARS-CoV-2 virus. The body recognizes the spike protein as an invader and produces antibodies against it. Soon after, the cell breaks down the mRNA into harmless pieces. If the antibodies later encounter the actual virus, they are ready to recognize and destroy it before it causes illness.

Unlike the Pfizer vaccine, which requires ultracold storage, the Moderna vaccine can be stored at normal freezer temperatures. This may allow for wider distribution to pharmacies and other facilities that are not equipped for ultracold storage.

In August 2021, the FDA granted full approval to the Pfizer/BioNTech COVID-19 mRNA vaccine for use in people ages 16 years and older. The transition from emergency use authorization (EUA) status to full licensure was based on additional data and longer follow-up showing that the vaccine met certain safety, effectiveness, and manufacturing quality standards.

Previous milestones for the Pfizer/BioNTech COVID-19 vaccine include the following:

The FDA granted its original EUA based on their own analysis of efficacy and safety data as well as on the recommendation made by the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10th. VRBPAC is a group of outside experts in infectious disease, vaccinology, microbiology, immunology, and other related fields.

Results from the Pfizer/BioNTech vaccine trial were published in theNew England Journal of Medicine. The data showed that the vaccine reduced the risk of COVID-19 by 95%. The trial enrolled nearly 44,000 adults, each of whom got two shots, spaced three weeks apart; half received the vaccine and half got a placebo (a shot of saltwater). Of the 170 cases of COVID-19 that developed in the study participants, 162 were in the placebo group and eight were in the vaccine group. Nine of the 10 severe COVID cases occurred in the placebo group, suggesting that the vaccine reduced risk of both mild and severe COVID.

According to theNEJMarticle, the vaccine was similarly effective in study participants of different races and ethnicities, body weight categories, presence or absence of coexisting medical conditions, and ages (younger and older than 65). It's worth noting that the FDA felt comfortable authorizing the vaccine for 16- and 17-year-olds, even though the number of teens enrolled in the study was small.

None of the study participants experienced serious side effects. However, most did have pain at the injection site. Also, about half of those receiving the vaccine reported mild to moderate fatigue or headache or both. Chills and fever were also fairly common. Symptoms almost always resolved within 24 to 48 hours.

The expanded EUA was based on results from a Phase 3 trial testing the Pfizer vaccine in children ages 12 to 15. The trial enrolled 2,260 adolescents; half received the Pfizer mRNA vaccine, the other received a saltwater placebo. The immune response in the vaccinated adolescent group was even stronger than that in vaccinated 16- to 25-year-olds enrolled in an earlier study. In addition, a total of 16 symptomatic cases of COVID-19 were reported during the trial, all in the placebo group. Vaccine-related side effects were mild and included pain at the injection site, tiredness, headache, chills, muscle pain, fever, and joint pain.

In granting full approval, the FDA analyzed data from 44,000 study participants and found that over six months of follow-up, the vaccine was 91.1% effective at preventing symptomatic COVID-19 infection. A subset of study participants was followed for six months to look at safety outcomes. A small but increased risk of two inflammatory heart conditions, myocarditis and pericarditis, was identified and will be noted in the FDAs prescribing information. Before granting full approval, the FDA also inspected vaccine manufacturing facilities to ensure vaccine quality.

This vaccine requires two doses, spaced three weeks apart. In January 2021, the CDC released guidance stating that while the second dose should be administered as close to the recommended three-week interval as possible, it may be scheduled for administration up to six weeks (42 days) after the first dose. Although the vaccine appears to provide reasonable protection after the first dose, it provides stronger protection after two doses. We do not yet know how long immunity from this vaccine will last.

The Pfizer/BioNTech vaccine is an mRNA vaccine. The vaccine contains synthetic messenger RNA (mRNA), genetic material that contains instructions for making proteins. Inside the body, the mRNA enters human cells and instructs them to produce a single component of the SARS-CoV-2 virus the "spike" protein found on the virus's surface. The body recognizes the spike protein as an invader and produces antibodies against it. If the antibodies later encounter the actual virus, they are ready to recognize and destroy it before it causes illness. mRNA vaccines must be stored at very cold temperatures; improperly stored vaccines can become inactive.

On February 27, 2021, the FDA granted emergency use authorization (EUA) for Johnson & Johnson's single-shot adenovirus vaccine, following the recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC). The vaccine is authorized for use in people 18 years and older.


Here is the original post: COVID-19 vaccines - Harvard Health
Moderna says COVID-19 vaccine protection wanes, makes case …

Moderna says COVID-19 vaccine protection wanes, makes case …

September 17, 2021

Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Moderna logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic

CHICAGO, Sept 15 (Reuters) - New data from Moderna Inc's (MRNA.O) large COVID-19 vaccine trial shows that the protection it offers wanes over time, supporting the case for booster doses, the company said in a news release on Wednesday.

"This is only one estimate, but we do believe this means as you look toward the fall and winter, at minimum we expect the estimated impact of waning immunity would be 600,000 additional cases of COVID-19," Moderna President Stephen Hoge said on a conference call with investors.

Hoge did not project how many of the cases would be severe, but said some would require hospitalization.

The data stands in stark contrast with data from several recent studies that suggested Moderna's vaccine protection lasts longer than a similar shot from Pfizer Inc (PFE.N) and German partner BioNTech SE .

Experts said the difference is likely due to Moderna's higher dose of messenger RNA (mRNA) and the slightly longer interval between the first and second shots.

Both vaccines proved to be exceedingly effective at preventing illness in their large Phase III studies.

Wednesday's analysis, however, showed higher rates of infection among people vaccinated roughly 13 months ago compared with those vaccinated roughly eight months ago. The study period was from July-August, when Delta was the predominant strain. It has yet to undergo peer review.

Moderna on Sept. 1 submitted its application to the U.S. Food and Drug Administration seeking authorization for a booster shot.

Hoge said data from its booster studies shows the vaccine could increase neutralizing antibodies to levels even higher than were seen after the second dose.

"We believe this will reduce COVID-19 cases," he said. "We also believe that a third dose of mRNA-1273 has a chance of significantly extending immunity throughout much of next year as we attempt to end the pandemic."

Briefing documents from the FDA's analysis of Pfizer's booster application, released earlier on Wednesday, suggest that a key issue the agency will consider is whether vaccine protection is waning.

In its analysis, Moderna compared the vaccine's performance in more than 14,000 volunteers vaccinated between July and October of 2020 with some 11,000 volunteers originally in the placebo group who were offered the shot between December 2020 and March 2021 following its U.S. emergency use authorization.

In the two-month period from July-August, researchers identified 88 COVID-19 cases among those who got the two shots more recently, compared with 162 cases among those vaccinated last year. Overall, only 19 cases were considered severe, a key benchmark in assessing waning protection.

Moderna said there was a trend toward a lower rate of severe cases among the more recently vaccinated, although the finding was not statistically significant.

Data from a separate study presented on Wednesday conducted with Kaiser Permanente Southern California health system, meanwhile, shows that Moderna's vaccine continued to perform well against the Delta variant.

Researchers compared data on more than 352,000 people who got two doses of the Moderna vaccine with the same number of unvaccinated individuals and found the Moderna vaccine was 87% effective at preventing a COVID-19 diagnosis, and 96% effective at preventing hospitalization.

Hoge said the vaccine's initial performance is strong, but argued that protection shouldn't be allowed to wane.

"The first six months are great, but you can't count on that being stable out to a year and beyond," he said.

(This story has been corrected to change year to 2021 from 2022 in 12th paragraph)

Reporting by Julie SteenhuysenEditing by Bill Berkrot and Karishma Singh

Our Standards: The Thomson Reuters Trust Principles.


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Moderna says COVID-19 vaccine protection wanes, makes case ...
Trump says Dems ‘disparaged’ COVID-19 vaccine while he was …

Trump says Dems ‘disparaged’ COVID-19 vaccine while he was …

September 17, 2021

EXCLUSIVE: Former President Donald Trump blamed Democrats for COVID-19 vaccine hesitancy among some Americans, saying they "disparaged" the vaccine when he was president.

During an exclusive interview with Fox News Digital, Trump reacted to President Bidens executive order last week, mandating employers with more than 100 workers to require coronavirus vaccinations or test employees weekly. Biden also announced that all employees of the federal government would be required to receive a COVID-19 vaccine.

"It shouldnt be necessary," Trump said, referring to the mandates which have drawn criticism from Republicans and some in the private sector.

SURGEON GENERAL: COVID NUMBERS DEEPLY CONCERNING, SAYS VACCINES DOING ITS JOB

The Trump administration created Operation Warp Speed, a public-private partnership to create vaccines against the novel coronavirus, as the pandemic raged in 2020. Under his administration, the Food and Drug Administration approved emergency use authorizations (EUA) for the Pfizer/BioNTech and Moderna COVID-19 vaccines.

Trump, in December 2020, signed an executive order that would ensure all Americans had access to coronavirus vaccines before the U.S. government could begin aiding nations around the world.

Trump, in the exclusive Fox News interview, said that during his administration, more people were interested in getting vaccinated against COVID-19.

"If you remember, when I was president, there were literally lines of people wanting to take it," Trump said, pointing to vaccine hesitancy among some Americans. "Now, you have a different situation, and its very bad."

Trump went on to point to comments made by some Democrats, including future Vice President Kamala Harris, who said they may not trust the effectiveness of a vaccine that he was pushing.

"Of course, they famously said, if Trump came up with it, Ill never take it," Trump recalled.

"They disparaged the vaccine, and now they wonder why people arent wanting to take it?" He continued. "Its a disgrace."

"Look, it was one of my greatest achievements doing it in less than nine months instead of five years, or maybe never," Trump said, referring to the approval timeline for some vaccines at the FDA. "We saved millions of people all over the world."

But pointing back to those against getting a jab, Trump said: "They dont trust this president, and thats why theyre not taking it."

Trump and former first lady Melania Trump received both doses of a COVID-19 vaccine in January at the White House. It is unclear which vaccine they received. Trump talked up the vaccines' benefits in an interview with Fox News' Greg Gutfeld last week, saying infections among the vaccinated were less severe compared to the unvaccinated at the start of the pandemic: "If you do get sick, you dont get sick like they were before, meaning you dont die."

BIDEN TO ANNOUNCE VACCINE MANDATE FOR COMPANIES WITH MORE THAN 100 EMPLOYEES

The Biden administration has made a significant push in promoting COVID-19 vaccines, launching door-to-door efforts over the summer, to help communities receive information and resources regarding how and when they could receive their doses.

The Biden administration, in July, also sought to incentivize Americans by urging state and local governments to use coronavirus relief funds to pay citizens $100 each to get vaccinated.

The proposals came amid concerns over breakthrough cases, infections among vaccinated individuals, and the strengthening delta variant became prominent in communities across the country.

CLICK HERE TO GET THE FOX NEWS APP

Meanwhile, with COVID-19 cases on the rise again in the U.S., health officials are urging the public to vaccinate themselves against the deadly disease, warning that the overwhelming majority of deaths and hospitalizations from the delta variant continue to be among unvaccinated Americans.

According to the Centers for Disease Control and Prevention, over 178 million people in the United States have been fully vaccinated against COVID-19.


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L.A. to require COVID vaccines at bars, nightclubs, more …

L.A. to require COVID vaccines at bars, nightclubs, more …

September 17, 2021

Proof of COVID-19 vaccination will be required at indoor bars, wineries, breweries, nightclubs and lounges in Los Angeles County under a forthcoming health order aimed at further armoring the region against the pandemic.

The mandate, which will be issued by Friday, will require patrons and employees to have at least one vaccine dose by Oct. 7 and be fully vaccinated by Nov. 4, according to Public Health Director Barbara Ferrer.

L.A. County, like the rest of the state and nation, has for months been battling the latest wave of the coronavirus, which has been fueled by the highly infectious Delta variant.

Though there are indications that the latest surge is losing some steam, officials are already turning a wary eye to the fall and winter, when the busy holiday season will bring people together from all over and colder weather will increasingly push gatherings and recreation indoors.

This is a reasonable path forward that will position us to be better able to break the cycle of surges, Ferrer said during Wednesdays L.A. County Board of Supervisors meeting.

About 67% of Angelenos have already been at least partially inoculated against COVID-19.

Under the new order, participants and workers at outdoor mega events with more than 10,000 attendees will also need to provide proof of vaccination or show that theyve recently tested negative for the coronavirus, starting Oct. 7. That requirement is already in place for indoor events of at least 1,000 people.

Ferrer said county health officials were also strongly recommending, though not requiring, vaccination verification at indoor portions of restaurants.

The countys requirement that residents wear masks in indoor public settings will remain in place, she added.

L.A. County is the most populous jurisdiction in California to announce a COVID-19 vaccination requirement to enter certain types of businesses.

The order would affect all areas of L.A. County except Long Beach and Pasadena, which have their own public health departments.

However, L.A. Countys order will not be as expansive as public health orders in some other parts of California. San Francisco and Berkeley require customers 12 and older in indoor restaurants, bars and gyms to show proof of a COVID-19 vaccination. Contra Costa County, the Bay Areas third most populous, has ordered those customers to show either proof of vaccination or a recent negative coronavirus test result. Palm Springs and neighboring Cathedral City have ordered patrons 12 and older to provide proof of COVID-19 vaccination or a recent negative coronavirus test to enter indoor restaurants and bars.

The L.A. City Council is considering its own law to require customers of indoor restaurants and gyms to have at least one dose of a COVID-19 vaccine. City attorneys are drafting a proposed ordinance.

When asked about L.A. Countys move during a briefing Wednesday, Gov. Gavin Newsom said state officials believe in localism and want to support local health decisions.

Though conditions could change, he indicated that the state had no immediate plans to follow suit.

Lately, the state has seen promising declines in case rates and the number of COVID-19 patients hospitalized, but Newsom pointed out that it was around this time last year we started to see that stabilization and decline as well, yet to experience that winter surge.

We need to be vigilant, he told reporters. Of course, the best way to mitigate that ... is to continue our vaccine efforts, and if this encourages more people to get vaccinated, then I believe its the right thing to do, and I continue to encourage others to follow that path.

About a month ago, Los Angeles County was averaging around 3,400 new coronavirus cases a day over a weekly period. As of Tuesday, L.A. County was averaging about 1,800 cases a day a 47% decline, according to a Times analysis of state data.

Nevertheless, coronavirus transmission levels remain elevated in the county, and unvaccinated people are still at high risk of getting infected. Unvaccinated people are also at far greater risk of being hospitalized.

Of the hundreds of people admitted to L.A. Countys public hospital system since June 15 for a diagnosis primarily due to COVID-19, 93% have been unvaccinated. Most of the vaccinated people who have been hospitalized have compromised immune systems and thus are not able to mount a sufficient immune response after vaccination, said Dr. Christina Ghaly, the countys director of health services.

Ferrer said L.A. Countys vaccination verification requirement was tailored to businesses that were considered to pose a greater risk of coronavirus transmission.

Although each establishment is different, Ferrer said, county health inspectors have noted settings where for the most part, all of the patrons, all the customers are there without a mask on mostly because they have a drink in hand. Theyre walking around and theres a lot of dancing, theres a lot of close contact with lots and lots of people.

This isnt all bars, she continued. I want to acknowledge that there are places where people go, its super quiet, you sit at a quiet table and the risk would obviously be less. But in general, the bars are higher-risk settings than restaurants.

She also noted that the establishments covered under the countys forthcoming order should already be well versed in checking identification to verify that patrons are of drinking age making it easier to also screen vaccination status.

Ferrer said residents could demonstrate their inoculation history using digital records provided by either the county or the state, or by showing their vaccine card or a photograph of it.

Some L.A. bars and restaurants have already implemented their own requirements of vaccination proof or a recent negative coronavirus test as a condition of entry.

Dustin Lancaster co-owns eight bars and restaurants in the L.A. area. In early August, he began requiring proof of vaccination for indoor seating at three of them.

If you want to sit inside at a bar, it makes 100% sense to me that you should be vaccinated, Lancaster said. The science is there, we know that vaccinations help decrease this, and all of our customers for the most part have been incredibly supportive and say, Thank you, and Im so glad youre doing this.

The new health order, he says, should alleviate some of the pressure on restaurateurs who have been struggling to enforce such requirements. He said he wished L.A. County would have implemented it sooner.

He also supports the mandates stipulation that employees be vaccinated.

With a labor shortage and breakthrough cases, running bars and restaurants right now is already so incredibly difficult, and we are under such immense stress, he said. I think anything that takes any pressure off of us and can be mandated at a higher level is good.

Lancaster said its been easier to enforce proof of vaccination at bars which usually require patrons be 21 or older as opposed to restaurants, where families with children younger than 12, who cannot yet be vaccinated, might dine.

Given the new county health order, Lancaster and his business partners will start to enforce vaccination requirements for indoor seating at some of their other establishments, such as Crawfords in Rampart Village and Oriel Chinatown.

Holcomb and the Hermosillo, both in Highland Park, are likely to follow suit.

In San Francisco, some bar owners also welcomed the local vaccine requirement to enter indoor bars and restaurants, which was announced in August.

As in L.A., some bars in San Francisco elected to impose their own vaccine requirement earlier in the summer.

Unvaccinated people are far more likely to be infected than those who are fully vaccinated, and bar owners were concerned about the health of their employees should they continue to allow unvaccinated people to enter their businesses.

Times staff writer Emily Alpert Reyes contributed to this report.


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Comparing the differences between COVID-19 vaccines – Mayo Clinic

Comparing the differences between COVID-19 vaccines – Mayo Clinic

September 17, 2021

Janssen/Johnson & Johnson - Side effects

Injection site pain, fatigue, headache, muscle pain, chills, fever and nausea

Note: If you received this vaccine within the last three weeks and are experiencing any unexplained new severe symptoms, seek emergency care.

Possible severe symptoms include shortness of breath, persistent stomach pain, severe or persistent headache, blurred vision, chest pain, leg swelling, easy bruising, and tiny red spots on the skin.

Rarely, some people may develop Guillain-Barre syndrome after getting the vaccine. Seek immediate medical care if you have weakness or tingling sensations, difficulty walking, difficulty with facial movements, double vision, and difficulty with bladder control.


Read the original post: Comparing the differences between COVID-19 vaccines - Mayo Clinic
Fauci slams Nicki Minaj for false COVID-19 vaccine tweet

Fauci slams Nicki Minaj for false COVID-19 vaccine tweet

September 17, 2021

Dr. Anthony Fauci threw cold water on Nicki Minajs claim that the COVID-19 vaccine can cause swollen testicles and lead to impotence.

The 38-year-old rap superstar made the claim when she explained her absence from the Met Gala in a now-viral tweet.

My cousin in Trinidad wont get the vaccine cuz his friend got it & became impotent. His testicles became swollen. His friend was weeks away from getting married, now the girl called off the wedding. So just pray on it & make sure youre comfortable with ur decision, not bullied, Minaj wrote Monday afternoon.

During an interview on CNN on Tuesday, Fauci was asked by host Jake Tapper whether there is any evidence that the Pfizer, Moderna or Johnson & Johnson jabs can adversely affect male or female reproductive systems.

The answer to that, Jake, is a resounding no. Theres no evidence that it happens nor is there any mechanistic reason to imagine that it would happen, so the answer to your question is no, President Bidens chief medical adviser responded.

The top infectious diseases doc added that the singers tweet may be innocent, but that she should be careful about what she posts about the deadly bug on social media, where she has more than 22 million followers on Twitter alone.

She should be thinking twice about propagating information that really has no basis except a one-off anecdote, and thats not what science is all about, Fauci said.

In another tweet, Minaj said: They want you to get vaccinated for the Met. if I get vaccinated it wont for the Met. Itll be once I feel Ive done enough research.Im working on that now.

She added: In the meantime my loves, be safe. Wear the mask with 2 strings that grips your head & face. Not that loose one.

The Starships singer was urged by some of her followers to rethink her stance on vaccines, citing research by the Centers for Disease Control and Prevention that shows they are effective at keeping people from contracting fatal cases.

But the hip-hop magnate, who has walked the Met Gala carpet five times before, doubled down.

Babe. Thats not true,she repliedbefore seemingly acknowledging that she previously caught the virus. I had the exact same symptoms as ppl with the damn vaccine.

Minaj also unleashed an expletive-laden tirade against MSNBCs Joy Reid for being so thirsty to down another black woman, after the TV host lectured her for her vaccine skepticism.

This is what happens when youre so thirsty to down another black woman (by the request of the white man), that you didnt bother to read all my tweets. My God SISTER do better imagine getting ur dumb a on tv a min after a tweet to spread a false narrative about a black woman, Minajtweeted.


View original post here: Fauci slams Nicki Minaj for false COVID-19 vaccine tweet
Which COVID-19 vaccine is the best? | Ohio State Medical Center

Which COVID-19 vaccine is the best? | Ohio State Medical Center

September 17, 2021

On Aug. 23, 2021, the U.S. Food and Drug Administration approved the Pfizer COVID-19 vaccine for the prevention of COVID-19 disease in people 16 and older. As what we know about COVID-19 evolves, so could the information contained in this story.Find our most recent COVID-19 blog posts here.

You might have already decided that you prefer one COVID-19 vaccine over another based on the characteristics of each of the options.

But the question of which vaccine is best doesnt have a straightforward answer. Considering the data we have available now as well as available vaccine supply, the vaccine thats best for you is likely the vaccine thats available to you.

The data right now suggests that both the Pfizer vaccine, which was formally approved by the FDA on Aug. 23, 2021, and the Moderna COVID-19 vaccine, which is authorized for emergency use, are very effective at preventing COVID-19 illness. The Johnson & Johnson vaccine is similarly effective in preventing severe COVID-19, and hospitalization and death from the virus.

The most important thing is just to get a COVID-19 vaccine, period.

Because of differences in the ways these vaccines were tested, it can be hard to compare them apples-to-apples. But heres what we know:

Clinical trial data shows that the Pfizer and Moderna vaccines are 95% and 94.1% effective, respectively, at preventing COVID-19 illness. This is extraordinary for a virus vaccine the annual flu vaccine, for example, is sometimes in the 50%-60% range of effectiveness at best, but is still so helpful at preventing illness that its recommended every year.

In clinical trials, the Johnson & Johnson COVID-19 vaccine showed 85% effectiveness in preventing severe COVID-19 and 100% effectiveness in preventing hospitalizations and death at 28 days after the injection.Get details on how the vaccines work.

All three of these COVID-19 vaccines include commonly reported side effects of pain/soreness at the injection site, headache, fatigue, muscle aches and nausea, which usually fully subsided within one to two days after vaccination.

The Moderna and Pfizer vaccines include some additional commonly reported side effects, such as chills, fever, joint pain and swollen lymph nodes. These side effects were more often reported after the second dose, though they are possible after either dose.

Since the Johnson & Johnson vaccine doesnt require a second dose, theres no increased risk of common side effects with a second dose.

Were trying to prevent:

Every vaccine available right now is much more effective than no vaccine, and they all significantly reduce the likelihood of severe illness and death. This means that even on the chance that someone gets infected after receiving a COVID-19 vaccine, theyre less likely to spread it to others and less likely to end up in a hospitals intensive care unit.

If we can get widespread immunization, we can decrease the community viral load (the amount of virus thats circulating), and the more people that are vaccinated, the better the vaccine works in a population.

Getting as much of our population as possible immunized with any FDA-approved COVID-19 vaccine will help us reduce the threat of disease, control the pandemic and move forward with our lives.

Andrew Thomas is chief clinical officer of The Ohio State University Wexner Medical Center and senior associate vice president for Health Sciences at The Ohio State University.


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Which COVID-19 vaccine is the best? | Ohio State Medical Center
Fact check: COVID-19 vaccine doesn’t cause symptoms in Nicki …

Fact check: COVID-19 vaccine doesn’t cause symptoms in Nicki …

September 17, 2021

Met Gala: Reaction to AOC, Kim Kardashian, Lil Nas X, JLO, more

From Rihanna and JLO's dates to AOC's dress and Nicki Minaj not attending, there was plenty to talk about with this year's Met Gala.

Entertain This!, USA TODAY

Superstar rapper Nicki Minajgenerated a dizzying amount of social media buzz after followingup her announcement that she wouldn't be getting vaccinated for the Met Gala with a personal story: A friend of her cousin in Trinidad developed swollen testicles and became impotent after receiving a COVID-19 vaccine.

"My cousin in Trinidad wont get the vaccine cuz his friend got it & became impotent. His testicles became swollen," the tweet, posted the evening of Sept. 13,read."His friend was weeks away from getting married, now the girl called off the wedding. So just pray on it & make sure youre comfortable with ur decision, not bullied."

The tweet has tens of thousands of Twitter users wondering what really happened, including Tucker Carlson, whoread the tweet to viewersjust a few hours after it was postedand aired a callout to the subject of the tweet on Sept.14.

The storywas also shared to othersocial media platforms, including in several widespreadInstagram posts.

More: Trinidad's Health Minister shuts down Nicki Minaj's vaccine claim: 'No reported such side effect'

But if you're hoping to avoid the mystery man's fate, medical experts say you're better off getting the shot than rejecting it.

While there's no evidence that the vaccine causes those symptoms, several studies have found COVID-19 can infect tissue in the testicles and penis, and it may have caused several cases of decreased sperm count and erectile dysfunction.

However, as several doctors noted in the replies to Minaj's tweet, this mystery person is likely dealing with a different condition.

"Its very worrisome that something said in a tweet, with no ill intentions, can impact someones choice about getting vaccinated," Raven Baxter, a molecular biologist who replied to Minaj's tweet with a rap about how vaccines work, told USA TODAY in an email."These vaccines are scientifically proven to be saving lives every day; the more people who get them, the better it is for all of us."

Fact check: COVID-19 vaccine protects both the person vaccinated and those around them

USA TODAY reached out to Minaj and users who shared the tweet for comment.

Theidentity of the man Minaj tweeted about remains unknown, butTrinidad & Tobago's health minister,Dr. Terrence Deyalsingh,said in a Sept. 15 news conference that no such case had been reported to his knowledge.

"What is sad about this is that it wasted our time yesterday trying to track this down," he said.

Regardless,experts say the situation Minaj described is inconsistent with what we know after hundreds of millions of vaccines have been administered.

Scientists and medical professionals who have studied the COVID-19 vaccine in depth say that there is no evidence of a link between the vaccine andimpotence or swollen testicles.

Physician of internal medicineDr. Rodney Hoodleads the National Medical Association's COVID-19 Task Force and other groups aiming to provide trusted, independent reviews of the vaccines to Black and underrepresented communities. He calledthe suggestion that the vaccine causes the symptoms in Minaj's tweet"a myth."

"Millions of doses of vaccines have been given, and none of thathas been reported as a potential side effect caused bythe vaccine,"he said.

Dr. Tom Shimabukuro, deputy director of the Centers for Disease Control and Prevention's Immunization Safety Office, also told USA TODAYthat scientists haven't found any evidence linking the symptoms in Minaj's tweet to the vaccine.

There is no scientific evidence that COVID-19 vaccines cause impotence and swollen testicles, he wrote in an email. "COVID-19 vaccines save lives."

More: Does COVID-19 vaccine cause infertility in men? Study shows mRNA vaccines do not decrease sperm count

Apeer-reviewed study from the University of Miami showedthat the Moderna and Pfizer vaccines do not affect sperm count, USA TODAY reportedin June.

"Swollen testicles and male infertility are definitely not potential or known side effects of any of the threeCOVID-19 vaccines that the FDA has authorized for emergency use in the USA," Dr. Matthew Laurens,an infectious disease specialist and vaccine researcher at the University of Maryland School of Medicine, wrotein an email to USA TODAY. "In fact, there is no evidence that any vaccine causes male fertility issues."

Fact check: A false post on social media claims COVID-19 vaccine causes infertility in women

So the vaccine has no link to infertility. But the virus it's helping prevent may, according to preliminary studies noted by Laurens and Hood.

"The vaccine will actually prevent you from getting a lot of the things that people are concerned with," Hood said."To me, there (is more evidence of)complications and (sexual function) problems even after you get over the acute phase of COVID than any evidence that we have from the vaccine."

One studyconducted this May at the University of Miami found that even men with mild COVID-19 symptoms could develop erectile dysfunction.

According to the study,otherwise healthy men developed impotencyafter COVID-19 infectionmade its way into their penile tissue. The scientists examined the tissue in two men who were undergoingpenile prosthesis surgeries.

One of the men in the study had been hospitalized for COVID-19, but the otherhad experienced only mild symptoms,researchers said.

As for testicular conditions, three differentstudiescited by Hood and Laurens have shown COVID-19 can infect the testes. That has the potential to negatively impact fertility, according to a report on oneconducted at the University of Miami.

Fact check: No evidence countries' vaccine rollout, leaders' deaths connected

Another study found decreased sperm counts in men who were infected with the virus, Laurens noted.

However, he said existing evidence on the link between COVID-19 and male infertilityisn't yet conclusive.

"There is preliminary evidence that the SARS-CoV-2 virus can affect semen volume, sperm concentration and the number of spermatozoa," Laurens wrote."Whether or not this translates into males who have COVID-19 experiencingfertility issues in the short or long-term is not yet known."

We rate the claim that the COVID-19 vaccine caused one man's swollen testicles and impotence MISSING CONTEXT, based on our research.Without knowing the specifics of the case Minaj described, it's not possible to know for sure what caused thesymptoms.However, medical experts say there have been no reports linking the vaccine to swollen testicles and impotence.

Contributing: Miriam Fauzia

Thank you for supporting our journalism.You cansubscribe to our print edition, ad-free app or electronic newspaper replica here.

Our fact-check work is supported in part by a grant from Facebook.


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Seattle area to require COVID-19 vaccine to enter indoor venues | TheHill – The Hill

Seattle area to require COVID-19 vaccine to enter indoor venues | TheHill – The Hill

September 17, 2021

Customers at Seattle-area restaurants, gyms and other indoor venues will soon be required to provide proof of vaccination against COVID-19 under a new county health order issued Thursday.

The order, which goes into effect Oct. 25, mandates that indoor restaurants and bars with the capacity to seat at least 12 people require all customers 12 years of age and older to provide proof of vaccination prior to entry.

The requirements also apply to indoor entertainment and recreational venues, including movie theaters, museums and sports arenas in Seattles King County.

County Health Officer JeffDuchin also noted in the order that starting Oct. 25, outdoor venues with 500 or more people must require attendees to provide proof of vaccination, with restaurants and bars with a seating capacity of less than 12 required to put a vaccine mandate in place starting Dec. 6.

Duchinnoted that in lieu of a vaccine card, customers and patrons may also present documentation of a negative PCR test taken within 72 hours, or a negative rapid test administered by a testing provider on site at the event site.

The order defines fully vaccinated against COVID-19 as 14 days past an individuals final dose of a Food and Drug Administration-approved vaccine.

Duchinsaid the order will remain in effect for at least six months, adding, I strongly recommend that employers and event organizers require vaccination for the workers and volunteers at the events and establishments covered by this order.

The mandate is similar to ones recently issued by citiessuch as New York and San Francisco for indoor events and activities as local governments aim to boost economic activity while also encourage more vaccinations amid the spread of the highly contagious delta variant.

According to data from the countrys health department, nearly 74 percent of the areas total population has received at least one dose of the COVID-19 vaccine, with 68 percent fully vaccinated.

In an effort to boost vaccination rates, the Washington state government has implemented inoculation requirements for state employees, school workers and health care workers.

Under Washington Gov. Jay InsleeJay Robert InsleeSeattle area to require COVID-19 vaccine to enter indoor venues Washington state troopers, firefighters sue over vaccine mandate Washington state enacting mask mandate for large outdoor events MOREs (D) mandate, all state employees must be fully vaccinated against COVID-19 by Oct. 18 or risk being blocked from working.

The measure has prompted pushback from some public employees, dozens of whom filed a lawsuit against Inslee last week, arguing that the mandate was an abuse of power and violated the states constitution.


More: Seattle area to require COVID-19 vaccine to enter indoor venues | TheHill - The Hill
UPMC Hosting Free COVID-19 Vaccine Clinics Across The Area This Weekend – CBS Pittsburgh

UPMC Hosting Free COVID-19 Vaccine Clinics Across The Area This Weekend – CBS Pittsburgh

September 17, 2021

By: KDKA-TV News Staff

PITTSBURGH (KDKA) If you are still in need of a COVID-19 vaccination, UPMC is hosting several clinics to get vaccinated.

Today there will be clinics in OHara Township, McKeesport, and Arlington Heights.

Then, on Saturday, there will be vaccination clinics at Bats Barbershop in East Liberty and Saint Clair Park in Greensburg.

Walk-ins are being accepted.

For full information about the clinics and their locations, check out this link.


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UPMC Hosting Free COVID-19 Vaccine Clinics Across The Area This Weekend - CBS Pittsburgh