Coronavirus cases are spiking elsewhere. Will L.A. County be hit hard or be spared? – Los Angeles Times

Coronavirus cases are spiking elsewhere. Will L.A. County be hit hard or be spared? – Los Angeles Times

‘Stealth omicron’ on the rise in North Dakota, but COVID-19 cases remain low – Bismarck Tribune

‘Stealth omicron’ on the rise in North Dakota, but COVID-19 cases remain low – Bismarck Tribune

April 2, 2022

The BA.2 omicron subvariant of the coronavirus is beginning to assert itself in North Dakota, and health officials are on guard.

The subvariant that's known to be even more infectious than the original omicron has caused new outbreaks in Europe and Asia and is now the dominant cause of COVID-19 in the U.S.,accounting for more than half of recent cases that have undergone the"sequencing" process through which variants are determined,according to the U.S. Centers for Disease Control and Prevention.

The so-called "stealth omicron" hasn't reached that level yet in North Dakota -- accounting for only about 5% of all specimens recently sequenced -- but confirmed cases are on the rise, according toKirby Kruger, head of the Health Department's disease control division and forensic pathology section.The coronavirus and its variants and subvariants have been slower to arrive in North Dakota than in some other parts of the country throughout the pandemic.

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About 5-10% of total positive COVID-19 tests weekly in North Dakota typically undergo the sequencing process, enough to give state health officials a sufficient sample size. State data shows 45 confirmed BA.2 cases, up eight from last week. At the beginning of the month, there were 14 cases.

"When looking only at the most recent specimens to be sequenced by our lab, we are starting to see a greater percentage of BA.2," Kruger said. "Of the specimens collected on or after March 20 and determined to be omicron, 27.5% were BA.2. So we are starting to see a greater proportion of BA.2."

Other known variants in North Dakota besides omicron are alpha, beta, gamma, delta, epsilon and mu, though there have been no cases of any but delta for months.

Scientists say one reason the BA.2 subvariant has gained ground is that its about 30% more contagious than the original omicron, according to The Associated Press. But it doesnt seem to cause more severe disease than the original, and vaccines appear just as effective against it. Unvaccinated people are at far greater risk.

"Because it is more infectious, we are watching to see if this subvariant may drive another increase in cases here," Kruger said.

"One additional monoclonal antibody has been found to be ineffective against the BA.2 subvariant," he added. "Vaccination and booster doses remain our best tool to prevent serious illness and hospitalizations."

Federal datashows that North Dakotacontinues to have some of the worst COVID-19 vaccination rates in the country: 65.3% of adults in the state are fully vaccinated, with the rate for all vaccine-eligible people -- age 5 and older -- at 58.8%.Neither rate increased over the week.The national averages are 75.5% and 69.7%, respectively.

COVID-19 booster shots are recommended for people 12 and older. North Dakota's booster rate is 41.7%, compared to 46.6% nationally.The state rate is unchanged from last week.

The U.S. Food and Drug Administration this week authorized second booster doses of Pfizer or Moderna COVID-19 vaccine for people age 50 and older, and for those age 12 and older with weakened immune systems. The CDC endorsed the additional booster. North Dakota's Health Department is urging eligible people to consider it.

Real-world data from Israel shows that an additional booster dose is safe and life-saving," state Immunization Director Molly Howellsaid. "Mortality due to the omicron variant in this data set was significantly lower -- a 78% reduction -- in those ages 60 and older in Israel who received an additional booster dose.

Molly Howell, the North Dakota Department of Health's immunization program manager

Weekly data

BA.2 isn't pushing COVID-19 cases up yet in North Dakota.

The Health Department's now-weekly coronavirus dashboard shows 193 new cases over the past week, compared with the previous three weekly totals of 242, 336 and 555 new cases, respectively.

The dashboard posted Friday showed that coronavirus patients made up just 2.5% of occupied inpatient beds statewide and about 6% of ICU beds. There were 19 COVID-19 admissions during the week, down from 32 the previous week and 56 the week before that.The two hospitals in Bismarck as of Thursday had atotalof six staffed inpatient hospital beds available and five intensive care unit beds open.

There have been 239,861 confirmed COVID-19 cases in North Dakota during the pandemic that began in March 2020. Data posted by the CDC shows 2,245 virus-related deaths, 13 more than last week. County-level death data is not available.

The state no longer reports the number of active COVID-19 cases, as part of its recent shift from daily public reporting to weekly reporting.

The data reported to the public now emphasizes trends over time and severity of disease, rather than daily case counts and test positivity rate -- data that state health officials say could be skewed by the fact that results from widely available COVID-19 home test kits are not required to be reported to the state.

More information

County-level COVID-19 risks determined by theCDC can be found athttps://bit.ly/3Clifrq. Burleigh and Morton counties both are considered at low risk, as is most of the state.

State Health Department guidance and resources for businesses is athttps://bit.ly/3w0DpKj.

Go tohttps://www.ndvax.orgor call 866-207-2880 to see where COVID-19 vaccine is available. Information on free public testing and free test kits is athealth.nd.gov/covidtesting. More detailed pandemic information is atwww.health.nd.gov/coronavirusandhttps://www.cdc.gov/coronavirus/2019-ncov/index.html.

Reach News Editor Blake Nicholson at 701-250-8266 or blake.nicholson@bismarcktribune.com.

Sign up now to get the most recent coronavirus headlines and other important local and national news sent to your email inbox daily.


Read more here: 'Stealth omicron' on the rise in North Dakota, but COVID-19 cases remain low - Bismarck Tribune
Regional health officials wrapping up coronavirus response | Serving Minden-Gardnerville and Carson Valley – The Record-Courier

Regional health officials wrapping up coronavirus response | Serving Minden-Gardnerville and Carson Valley – The Record-Courier

April 2, 2022

A National Guardsman conducts helps conduct community coronavirus testing at East Fork Station 12 in Sunridge on Dec. 8, 2020. Official said 440 people were tested during the event.Photo by Kurt Hildebrand.

Today marks the last day Douglas residents may call the Quad-County COVID-19 hotline.

While information will still be posted to gethealthycarsoncity.org, the hotline at (775) 283-4789 has been open since at least March 12, 2020, when the first case of coronavirus was reported by Carson City Health and Human Services.

Five days after the first case in Carson City was announced, Nevada was ordered into a statewide lockdown.

Friday also marked two years to the day that it was announced that the Nevada National Guard would aid in the states response to the coronavirus.

Guard members served at testing events across the four counties, providing assistance to regional health authorities.

The Guards mission officially wraps up today. At the peak of the Guards involvement in April 2020, there were 1,139 members assisting the state, the largest domestic emergency response in its history. With Guard members on orders for more than 700 days, it was also the longest deployment in state history.

A total of 1,400 Nevada Guard members directly administered 821,227 coronavirus tests and 818,661 vaccinations across the state.

They also conducted traffic control and wrangled paperwork for the testing and vaccination clinics.

Vaccination clinics are expected to continue through April, though after that residents will have to obtain vaccinations through pharmacies.

Carson City Health and Human Services will conduct clinics 2:30-4 p.m. April 14 and April 28 at the Douglas County Community & Senior Center, 1329 Waterloo Lane, Gardnerville.

While the Pfizer and Moderna vaccines will be available, Janssen vaccines will stop being offered on April 11.

According to the Nevada Health Response homepage, Douglas County was seeing one new daily confirmed case of the virus after a total of 6,597 cases over the last two years. That figure is likely to be low, as residents self-testing isnt reported to the state.

Douglas County Emergency Management reported distributing 9,000 free self-test kits in the state.

No new hospitalizations have been reported and 91 deaths have been attributed to the virus since the first in August 2020. Nine of those deaths have occurred since Feb. 7, according to Nevada Health Response.


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Regional health officials wrapping up coronavirus response | Serving Minden-Gardnerville and Carson Valley - The Record-Courier
CDC confirms risk of heart issues after COVID-19 infection, 2nd vax dose – WFLA

CDC confirms risk of heart issues after COVID-19 infection, 2nd vax dose – WFLA

April 2, 2022

TAMPA, Fla. (WFLA) For the millions of Americans that have gotten COVID-19, the health care journey isnt over. The U.S. Centers for Disease Control and Prevention confirmed in a new report that the risk of cardiac complications persists following infection and recovery.

The report released April 1 paints the picture of ongoing risks and negative health outcomes that could spring up after a patient has gotten COVID-19. The report also touches on the potential risk of heart issues after receiving an mRNA vaccine for the coronavirus. The two mRNA vaccines available are from Pfizer and Moderna.

The report said cardiac complications, particularly myocarditis and pericarditis, have been tied to COVID-19 infection and mRNA COVID-19 vaccination. Additionally, the study by the CDC found cases of multisystem inflammatory syndrome, which the health agency described as a rare but serious complication of SARS-CoV-2 infection with frequent cardiac involvement.

The study found the risk for all three cardiac conditions was increased between one and three weeks after infection or vaccination.

In some respects, the CDC report provides support to a stance taken weeks ago by the DeSantis administration and Florida Department of Health specifically, the updated guidance provided by State Surgeon General Dr. Joseph Ladapo which recommended against healthy children receiving COVID-19 vaccines.

Male youths were the patient group with the highest level of risk for developing the cardiac conditions after both vaccination and infection. For male patients 12 to 17 years old, the CDC said the risk for cardiac outcomes was highest after the second vaccine dose from an mRNA vaccine, but was even higher after a COVID-19 infection.

The incidence of cardiac outcomes after mRNA COVID-19 vaccination was highest for males aged 1217 years after the second vaccine dose; however, within this demographic group, the risk for cardiac outcomes was 1.85.6 times as high after SARS-CoV-2 infection than after the second vaccine dose, the CDC said. The risk for cardiac outcomes was likewise significantly higher after SARS-CoV-2 infection than after first, second, or unspecified dose of mRNA COVID-19 vaccination for all other groups by sex and age.

However, the CDC study specifically focuses on risks from mRNA vaccines, meaning the Johnson & Johnson shot is not included in the treatments and prevention options that may provide additional risks to patients.

The CDC said due to their findings, they continue to support use of the mRNA vaccines for COVID-19 among all eligible patients, being anyone 5 years or older.

In an updated FDOH guidance released on March 8, the state health department included the following risks for vaccination, when recommending against receiving the shots:

The FDOH cited studies to support their recommendation.

At the time, the CDC remained supportive of vaccination, and the U.S. Food and Drug Administration said the vaccines had continued to prove safe and effective.

The new CDC study still supports use of COVID-19 vaccinations, though it found the risks were higher among young, biologically male patients, rather than all patients between 12 and 17 years old.

The study data used was pulled from 40 health care systems to study the risk of cardiac complications from COVID-19 and mRNA vaccinations for COVID-19, among male and female patients across multiple age demographics.


Go here to read the rest: CDC confirms risk of heart issues after COVID-19 infection, 2nd vax dose - WFLA
Covid vaccines give extra protection to previously infected, studies show – The Guardian

Covid vaccines give extra protection to previously infected, studies show – The Guardian

April 2, 2022

Covid-19 vaccines provide significant extra protection for people who have already been infected, according to two new studies.

The jabs have proven highly effective in protecting those who have never had Covid, but their effectiveness at preventing symptoms and severe outcomes in people who have previously been infected has, until recently, been less clear.

Now two separate pieces of research, published in the Lancet Infectious Diseases journal, confirm that Covid-19 vaccines provide additional protection for people who have already been infected with Sars-CoV-2 especially against severe disease.

In the first study, conducted in Brazil, researchers found that four vaccines CoronaVac, Oxford/AstraZeneca, Janssen and Pfizer/BioNTech provide extra protection against symptomatic reinfection and severe outcomes such as hospitalisation and death in people who had previously caught coronavirus.

The second study, from Sweden, found that vaccination against Covid-19 provided additional protection to those who had had Covid before, for at least nine months.

Together, the studies provide crucial data on vaccine effectiveness in people with a prior infection and underline the benefits of getting vaccinated regardless of whether someone has had Covid. Experts say the findings could also help inform global vaccine strategies.

Covid-19 vaccines have been proven to be highly effective at preventing symptomatic infection and hospitalisation among those with no prior infection but effectiveness for those with prior infection is less clear, said the author of the first study, Julio Croda, of Universidade Federal de Mato Grosso do Sul and Fundao.

Understanding the duration and effectiveness of immunity for those vaccinated with a previous Covid-19 diagnosis becomes increasingly important as the pandemic progresses and surges new cases may occur as a result of more transmissible variants. Further research on the need for vaccination for those with a previous Covid-19 infection is a vital step to pandemic policy intervention including guidance on single dose or two dose vaccine protection.

In the first study, which involved more than 22,000 people who became reinfected with Covid, the data showed that being vaccinated reduced their risk of symptoms, being hospitalised or dying.

All four of these vaccines have proven to provide significant extra protection for those with a previous Covid-19 infection, reducing hospitalisation and death, said Croda. There has been ongoing public debate about whether previously infected individuals need to be vaccinated. Our results suggest that vaccine benefits far outweigh any potential risk and support the case for vaccination, including the full vaccine series, among individuals with prior Sars-CoV-2 infection.

Writing in the same journal, Pramod Kumar Garg, of the Translational Health Science and Technology Institute, India, who was not involved in the study, said: The results of [the Brazil] study and other recent studies challenge the concept of population-level herd immunity through natural infection alone against Sars-CoV-2 and suggest that vaccinating individuals who were previously infected provides further protection, particularly against severe disease. These data should help guide policy decisions and mitigate vaccine hesitancy among people who had Sars-CoV-2 infection.

The second study, involving almost 3 million people, found that one vaccine dose in someone with infection-driven immunity from a previous infection lowered their risk of reinfection by 58% two months after the jab. Two doses of vaccine lowered the risk of infection by 66%.

The authors acknowledged limitations with both studies, including a risk of bias due to the observational nature of the research. Additionally, neither study included an analysis of reinfection from the Omicron variants.

Writing in the same journal, Jennifer Juno, of the University of Melbourne, Australia, who was not involved in either study, said: These data confirm, in a large cohort, the added protective benefit of vaccination among individuals recovered from Covid-19.


Originally posted here:
Covid vaccines give extra protection to previously infected, studies show - The Guardian
Coronavirus Omicron variant, vaccine, and case numbers in the United States: April 1, 2022 – Medical Economics

Coronavirus Omicron variant, vaccine, and case numbers in the United States: April 1, 2022 – Medical Economics

April 2, 2022

Total vaccine doses distributed: 702,957,265

Patients whove received the first dose: 255,534,750

Patients whove received the second dose: 217,639,435

% of population fully vaccinated: 65.6%

% of infections tied to the Omicron Variant: 100%


The rest is here: Coronavirus Omicron variant, vaccine, and case numbers in the United States: April 1, 2022 - Medical Economics
Most Americans no longer wear masks in public; vaccinated pregnant women have less protection from the virus – cleveland.com

Most Americans no longer wear masks in public; vaccinated pregnant women have less protection from the virus – cleveland.com

April 2, 2022

CLEVELAND, Ohio Most Americans have stopped wearing masks in public; and pregnant women vaccinated against COVID-19 are more likely to get breakthrough infection, a new study suggests.

Cleveland.com is rounding up some of the most notable coronavirus news making headlines online. Heres what you need to know for Friday, April 1.

Most Americans have dropped mask wearing, new poll finds

A majority of Americans are not wearing masks in public, according to a new national poll.

The Associated Press and the National Opinion Research Center poll found just 44% of adult respondents still wear a mask often or always when in public. Thats down from 65% of adults who said they wore masks in a January AP-NORC poll.

The pollsters surveyed 1,082 U.S. adults between March 17-21.

In February 2021, about 82% of those polled said they were always or often wearing a mask in public, and more than 75% were staying away from large groups.

Vaccinated pregnant women have less protection from the virus than other patients, study suggests

Vaccinated pregnant women are nearly twice as likely to get a breakthrough COVID-19 infection as those who are not pregnant, suggests a new study.

The new study from the U.S. Centers for Disease Control and Prevention suggests that even pregnant women who are fully vaccinated tend to have less protection from the virus than many other patients with significant medical problems.

The analysis, based on medical records of nearly 14 million American patients since COVID-19 vaccines became available, found that pregnant women who are vaccinated have the greatest risk of developing COVID-19 among a dozen medical conditions, including being an organ transplant recipient and having cancer.

COVID-19 increases the risk of pregnancy complications, such as premature births.

Patients with COVID-19, flu risk severe illness and death, study suggests

Hospitalized patients with COVID-19 and influenza have much higher risk of severe illness and death than those who have COVID-19 alone, a new United Kingdom study suggests.

We found that the combination of COVID-19 and flu viruses is particularly dangerous. This will be important as many countries decrease the use of social distancing and containment measures, said study co-author Kenneth Baillie, a professor of experimental medicine at the University of Edinburgh, in a university news release.

The U.K. study looked at data from nearly 7,000 adults in the U.K. who were hospitalized with COVID-19 between February 2020 and December 2021. These patients were also tested for other respiratory viruses.

The 227 patients who had both COVID-19 and the flu were over four times more likely to require breathing support and 2.4 times more likely to die than those with COVID-19 alone, according to the study.

The Lancet recently published the findings. The CDC website explains the similarities and differences between COVID-19 and the flu.

J&J shot plus Pfizer or Moderna is less protective, study suggests

Americans who received the one-shot Johnson & Johnson COVID-19 vaccine have less protection against serious illness and hospitalizations than those who got the Pfizer-BioNTech and Moderna shots, suggests a recent CDC study.

Even combining a J&J vaccine with a booster of either J& J, or one of either Pfizer or Moderna both messenger RNA vaccines wasnt as strong as three shots of Pfizer or Moderna in preventing emergency room visits or hospitalizations, according to a CDC report.

About 17 million Americans got the J&J shot, according to federal statistics.

The latest data suggest J& J vaccine recipients should get a booster with one of the messenger RNA vaccines, and consider a second messenger RNA booster for the greatest protection.

The CDC analyzed the results of mix-and-match vaccine-and-booster combinations during four months when the highly transmissible omicron variant was dominant. The study is important because vaccine effectiveness data on the mix-and-match booster strategies in the real world has been limited.


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Most Americans no longer wear masks in public; vaccinated pregnant women have less protection from the virus - cleveland.com
Does the COVID Vaccine Contain the Virus? No … – NBC Chicago

Does the COVID Vaccine Contain the Virus? No … – NBC Chicago

April 2, 2022

Does the COVID vaccine contain the virus? No, and it won't make you "shed" spike proteins or transmit COVID-19 to others in any way, experts say, explaining how the vaccines work in an effort to swat down rumors and misinformation.

Misinformation about the coronavirus has been rampant on social media since the pandemic began, and vaccinations are no different. One rumor that's popped up is that unvaccinated people can get sick simply from contact with those who have gotten the COVID vaccine as they "shed" viral particles.

Public health experts and medical professionals across the board say that this type of "shedding" is absolutely not happening with the COVID vaccines - and that understanding how the vaccines work is key to knowing the truth.

There are currently three different COVID vaccines available in the U.S. The Pfizer-BioNTech vaccine and the Moderna vaccine are both two-dose mRNA vaccines, while the Johnson & Johnson vaccine is a single-shot that uses an adenovirus. Importantly, none contain the live coronavirus that causes COVID-19.

The Pfizer-BioNTech and Moderna vaccines differ from traditional vaccines in their use of mRNA, a relatively new technology. Instead of introducing a weakened or an inactivated germ into your body, these vaccines inject mRNA, the genetic material that our cells read to make proteins, into your upper arm muscle.

According to the Centers for Disease Control and Prevention, "mRNA stands for messenger ribonucleic acid and can most easily be described as instructions for how to make a protein or even just a piece of a protein."

The mRNA vaccines contain those instructions for the distinctive spike protein found on the surface of the coronavirus and which attaches to a particular protein in our body. Once the mRNA is inside your muscle cells, the cells translate the information to make the protein or antigens anddisplay it on their surface, according to Pfizer. Your immune system spots the antigens, recognizes them as foreign and begins to make antibodies.

Essentially, the vaccine teaches your body how to make the protein that triggers antibody production so if the real virus later enters your body, your immune system will recognize and fight it, according to the CDC.

Unlike the Pfizer and Moderna shots, the J&J vaccine use a cold virus, called an adenovirus, to carry the spike gene into the body.

J&Js shot uses the cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along.

The CDC notes thatnone of the vaccinesuse the live virus that causes COVID-19. The Pfizer mRNA vaccine, for example, contains instructions for making a harmless piece of just one of the coronavirus' 29 proteins and your body breaks down those instructions and gets rid of them once it has made the spike protein.

"This vaccine is not a live vaccine," Dr. Sharon Welbel, the director of Hospital Epidemiology and Infection Control for Cook County Health said in December as vaccinations were just beginning.

"The vaccine is a little snippet of the genetic code of the virus that causes COVID-19. It instructs our bodies how to create a protein that's specific to the virus and then we develop our own antibodies," Welbel said.

The CDC also notes the vaccine won't make people test positive for coronavirus, though it could cause a positive antibody test.

Typically, a vaccine puts a weakened or inactivated virus into our bodies to trigger an immune response, which then produces antibodies. Those antibodies are what ultimately protect us from getting infected if we ever encounter the real thing.

According to the CDC, mRNA vaccines don't contain the virus in any form but instead contain the material to "teach our cells how to make a proteinor even just a piece of a proteinthat triggers an immune response inside our bodies."

In order to "shed" coronavirus particles, you would have to have the live coronavirus in your body, experts say - and none of the available vaccines contain the live virus in any amount.

"None of the COVID-19 vaccines can make you sick with COVID-19, nor do they contain the live virus in any amount," says Cook County Department of Public Health' Senior Medical Officer and Co-Lead Dr. Kiran Joshi."COVID-19 vaccines teach our immune systems how to recognize and fight the virus that causes COVID-19."

To this, Joshi also said no: "None of the authorized COVID-19 vaccines contain the live virus that causes COVID-19. This means that a COVID-19 vaccine cannot make you sick with COVID-19, and you cannot transmit the virus to others."

"No. Vaccines train our immune systems to create proteins that fight disease, known as antibodies, just as would happen when we are exposed to a disease but crucially vaccines work without making us sick," Joshi said.

"COVID-19 vaccines help our bodies develop immunity to the virus that causes COVID-19 without us having to get the illness."

"mRNA is not able to alter or modify a persons genetic makeup (DNA). The mRNA from a COVID-19 vaccine never enter the nucleus of the cell, which is where our DNA are kept," the CDC says. "This means the mRNA does not affect or interact with our DNA in any way. Instead, COVID-19 vaccines that use mRNA work with the bodys natural defenses to safely develop protection (immunity) to disease."

Mayo Clinic also said "injecting messenger RNA into your body will not interact or do anything to the DNA of your cells."

"Human cells break down and get rid of the messenger RNA soon after they have finished using the instructions," the clinic's website reads.


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Does the COVID Vaccine Contain the Virus? No ... - NBC Chicago
Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals | FDA – FDA.gov

Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals | FDA – FDA.gov

April 2, 2022

For Immediate Release: March 29, 2022

Espaol

Today, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. The FDA previously authorized a single booster dose for certain immunocompromised individuals following completion of a three-dose primary vaccination series. This action will now make a second booster dose of these vaccines available to other populations at higher risk for severe disease, hospitalization and death. Emerging evidence suggests that a second booster dose of an mRNA COVID-19 vaccine improves protection against severe COVID-19 and is not associated with new safety concerns.

The agency amended the emergency use authorizations as follows:

Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research. Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19. So, those who have not received their initial booster dose are strongly encouraged to do so.

Todays action applies only to the Pfizer-BioNTech and Moderna COVID-19 vaccines and the authorization of a single booster dose for other age groups with these vaccines remains unchanged. The agency will continue to evaluate data and information as it becomes available when considering the potential use of a second booster dose in other age groups.

The FDA-authorized Pfizer-BioNTech COVID-19 Vaccine and the FDA-approved Comirnaty can be used to provide the authorized booster dose(s). Similarly, the FDA-authorized Moderna COVID-19 Vaccine and the FDA-approved Spikevax are authorized to provide the authorized booster dose(s).

Information to Support Authorization of a Second COVID-19 Booster Dose

The FDA has determined that the known and potential benefits of a second COVID-19 vaccine booster dose with either of these vaccines outweigh their known and potential risks in these populations. The evidence considered for authorization of a second booster dose following primary vaccination and first booster dose included safety and immune response information provided to the agency as well as additional information on effectiveness submitted by the companies.

A summary of safety surveillance data provided to the FDA by the Ministry of Health of Israel on the administration of approximately 700,000 fourth (second booster) doses of the Pfizer-BioNTech COVID-19 Vaccine given at least 4 months after the third dose in adults 18 years of age and older (approximately 600,000 of whom were 60 years of age or older) revealed no new safety concerns.

The safety of Moderna COVID-19 Vaccine, when administered as a second booster dose, is informed by experience with the Pfizer-BioNTech COVID-19 Vaccine and safety information reported from an independently conducted study in which the Moderna COVID-19 Vaccine was administered as a second booster dose to 120 participants 18 years of age and older who had received a two-dose primary series and a first booster dose of Pfizer-BioNTech COVID-19 Vaccine at least 4 months prior. No new safety concerns were reported during up to three weeks of follow up after the second booster dose.

Immunogenicity data from an ongoing, open-label, non-randomized clinical study in healthcare workers at a single center in Israel were reported in a publication provided to the FDA. In this study, individuals 18 years of age and older who had received primary vaccination and a first booster dose with Pfizer-BioNTech COVID-19 Vaccine were administered a second booster dose of Pfizer-BioNTech COVID-19 Vaccine (154 individuals) or Moderna COVID-19 Vaccine (120 individuals) at least four months after the first booster dose. Among these individuals, increases in neutralizing antibody levels against SARS-CoV-2 virus, including delta and omicron variants were reported two weeks after the second booster as compared to 5 months after the first booster dose.

The amendments to the EUAs to include a second booster dose for these populations were granted to Pfizer Inc. and ModernaTX Inc.

###

Boilerplate

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

03/29/2022


Read the original here: Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals | FDA - FDA.gov
Covid-19 hospitalizations hit a pandemic low in the US, but strain on hospitals persists – CNN

Covid-19 hospitalizations hit a pandemic low in the US, but strain on hospitals persists – CNN

April 2, 2022

As of Friday, there are 16,138 people in the hospital with Covid-19 -- fewer than there have ever been since the US Department of Health and Human Services first started tracking in July 2020. Just 2% of hospital beds are currently in use for Covid-19 patients.

Previously, the lowest point was in late June 2021, just before Delta became the dominant variant in the country. Covid-19 hospitalizations reached a peak in January 2022 amid the Omicron surge, when more than 160,000 people were hospitalized with Covid-19 at one time.

While the strain on the US hospital system directly related to treating Covid-19 patients has been significantly reduced, experts say that many hospitals are still burdened by staffing shortages and other patients who are coming in sicker after postponing care during the height of the pandemic.

"I can't hear that (data on Covid-19 hospitalizations) without shouting 'hallelujah' because the stress and strain of the last two years has been so enormous," Nancy Foster, vice president for quality and patient safety policy at the American Hospital Association, told CNN. "But there are a number of things going on now that continue to make hospitals and their staff very busy."

She says hospitals expected an influx of patients who had delayed care, either by choice or because the hospital system couldn't accommodate them.

"But I think it is that combination of having more people needing care than we had anticipated and having more staffing issues than we had anticipated that is really the biggest challenge right now," she said.

The broader snapshot of hospital capacity offers a stark contrast to the CDC's "COVID-19 Community Levels" map, which tracks new hospital admissions and beds in use specifically for Covid-19 patients.

The CDC map is nearly all green, with 95% of US counties considered to have a "low" community level of Covid-19.

But HHS data shows that more than three-quarters of inpatient beds are currently in use in hospitals across the country, and there are nine states where more than 80% of all beds in the state are occupied.

Experts say it's important to monitor both broader hospital capacity and the burden specifically from Covid-19.

"From an endemic Covid monitoring perspective -- at least that's where we hope we're heading -- we need to be able to tell whether we're in a state that requires public health measures," Dr. Stephen Parodi, national infectious disease leader for Kaiser Permanente, told CNN.

But the pandemic has dramatically shifted the way hospitals operate. Pre-pandemic, there was typically seasonal variation in how many beds were filled, with more patients expected during flu season in the winter and a lighter volume over the summer.

"What's different now, since the pandemic, is essentially we're running full all the time," Parodi said. "That calculation of a plan -- when it comes to staffing those beds, having the workforce available, the doctors, nurses, the support services like laboratory and radiology -- it's changing our thinking about what we need to plan for an entire year as opposed to just one particular season."

Parodi and others expect the continued strain on capacity to persist at least through the end of the year.

Overall since August 2020, there have been about 4.6 million total hospital admissions for Covid-19 in the US, according to data from the CDC. More than a third of hospital admissions have been among seniors age 70 and older.

Black and Hispanic people have been hospitalized with Covid-19 at more than twice the rate of White people, and American Indians have been more than three times as likely to be hospitalized.


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Covid-19 hospitalizations hit a pandemic low in the US, but strain on hospitals persists - CNN
Why COVID-19 reinfections are surging in England – ABC News

Why COVID-19 reinfections are surging in England – ABC News

April 2, 2022

As COVID-19 cases continue to rise in England, the country is also experiencing a surge in reinfections.

Provisional data shows that, as of the week ending March 20, 2022, laboratory-confirmed reinfections -- two positive tests taken more than 90 days apart -- have surpassed 50,000 per week in England, 10.7% of all cases, according to a weekly report from the U.K. Health Security Agency published Thursday.

This is a jump from the less than 20,000 weekly reinfections recorded during the last week of February in England.

The weekly rate is increasing in all age groups and has nearly doubled in one week among those aged 30 and older, the report shows.

Vaccination rates are high in England with 85.8% of those aged 12 and older fully vaccinated and 66.8% boosted.

Additionally, as of Friday, 99% of the adult population in England is estimated to have detectable COVID-19 antibodies either from previous infection or from vaccination, according to the U.K. government.

There were only 7,093 reinfections reported in Scotland, 10.4 percent of all cases, in the week ending March 27. Recent data on reinfections were not readily available for Wales and Northern Ireland.

A person stands outside a COVID-19 testing center in London, Feb. 21, 2022.

So, with such high coverage, why have so many in England been reinfected with COVID-19?

Experts said there are a few reasons for the uptick including the spread of the BA.2 variant, waning immunity and the further relaxing of COVID-19 mitigation measures in England.

BA.2 is more transmissible

Dr. Ali Mokdad, an epidemiologist with the University of Washington's Institute for Health Metrics and Evaluation in Seattle, told ABC News the spread of the BA.2 variant is undoubtedly playing a role in the rise of reinfections in England.

"BA.2 is more infectious so more people can be infected by being exposed to it," he said. "The time needed for you and me to sit close together to get the infection is much shorter."

BA.2, which is a subvariant of the original omicron variant, has become the dominant variant in England.

Data from the UKHSA estimates BA.2 currently accounts for 93.7% of all COVID-19 cases in England. Less than two months ago, it made up less than 5% of cases

A preprint from Sweden, which has not yet been peer-reviewed, suggests BA.2 may be more contagious due to higher viral loads in the nose and throat than the original BA.1 variant.

Early data from the U.K. and Denmark also suggests it is possible to be infected with BA.2 after having been infected with BA.1, although this is less likely.

Mokdad said the numbers from these studies are too low to warrant any serious concern.

It is unclear from the U.K. data how many of the reinfected cases are among those who are fully vaccinated and those who are boosted.

However, several studies have shown booster shots lower the risk of reinfection.

An Israeli study published in JAMA Internal Medicine in November 2021 found 1.8% of COVID-19 tests were positive in adults that were boosted compared to 6.6% in adults that had two shots.

While BA.2 is more transmissible than BA.1, it does not appear to increase the risk of hospitalization.

A passenger passes a sign for a Walk Through Coronavirus Testing Centre at London Stansted Airport, on Jan. 10, 2022.

Professor David Heymann, from the department of infectious disease epidemiology at the London School of Hygiene & Tropical Medicine, said the rise of reinfections should not concern people because the number of hospitalizations and deaths remains low.

"The vaccines are suppressing serious illness and death, even if you get reinfected," he told ABC News. "What we do know is there's no cause for real alarm at present because the hospital surveillance is showing COVID remains a minor disease" for the vaccinated.

Waning immunity

Mokdad said many people who got their second dose, or even their third dose, received it five to six months ago so their immunity will have waned by now.

"What we know from the data -- and we have a lot of evidence, including from the UK -- is that, starting at three months your immunity, especially against infection, drops rapidly," Mokdad said. "And by five months, your immunity against infection is basically 20%."

A January report from the UKHSA found the effectiveness of two doses of the AstraZeneca vaccine, which is what most people in the U.K. have received, dropped from 50% against omicron to virtually no effect 20 weeks later.

A booster from either Pfizer or Moderna raised the protection against omicron to around 60%, but it fell to as low as 40% 10 weeks later.

Mokdad said for those who weren't infected with the original omicron variant during the last wave, this also increases the risk of reinfection because contracting the virus will have acted like a natural booster shot for most healthy individuals.

Behavioral changes

Experts say behavioral changes after restrictions were lifted are also likely playing a role in the rise of reinfections.

U.K. Prime Minister Boris Johnson had been lifting COVID restrictions in England since the beginning of the year and, on Feb. 25 dropped all remaining rules for the country, including the requirement to self-isolate after testing positive, contact tracing and free administration of rapid tests.

The announcement applied only to England, which is home to 56 million of the U.K.s 67 million people, the Associated Press reported in February.

People queue outside a coronavirus disease testing facility in central London, Jan. 2, 2022.

This means many people are no longer wearing masks or staying home from work or school, or self-isolating if they are ill.

"Suddenly, they lifted these mandates," Mokdad said. "People are tired and have changed their behavior. Suddenly, you have 30% or 40% susceptible because of waning immunity and the fact they have not been exposed to BA.1, and BA.2 is circulating, then you see this rapid increase in cases.

When Johnson lifted the mandates, he gave a speech to the House of Commons in which he stated he wanted England to pivot away from preventing COVID-19 and "learn to live with this virus."

Professor Daniel Altmann, from the department of immunology and inflammation at Imperial College London, said this has led to "confusion" about how to prevent reinfection.

"This means that people are confused about safety -- many are going out to work and school when knowingly infected, fewer wearing masks," he told ABC News. "It looks like an untenable policy when one considers omicron, somewhat milder but poorly immunogenic and able to reinfect people sometimes over and over at intervals of a few weeks."


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