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September 22, 2021: FDA authorizes Pfizer-BioNTech COVID-19 Vaccinebooster dose for certain populations.View press release.
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The U.S. Food and Drug Administration approved Comirnaty for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older. The vaccine has the same formulation as the Pfizer-BioNTech COVID-19 Vaccine that continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age,for the administration of a third dose in certain immunocompromised individuals, and for a single booster dose in certain populations.
Comirnaty
Three COVID-19 vaccines are authorized for emergency use. The vaccines are:
Pfizer BioNTech COVID-19 Vaccine
Moderna COVID-19 Vaccine
Janssen (sometimes called Johnson & Johnson) COVID-19 Vaccine
Emergency use authorization (EUA) allows these vaccines to be distributed in the U.S. Learn more about EUAs for COVID-19 vaccines from the FDAs Center for Biologics Evaluation and Research (CBER).
The FDA is the regulatory authority with oversight of the safety, effectiveness and quality of vaccines that are used in the U.S., including COVID-19 vaccines. Career scientists and doctors at the FDA determine whether to approve or authorize COVID-19 vaccines after they thoroughly analyze and evaluate the data submitted by the manufacturer related to safety, effectiveness and manufacturing quality.
During a public health emergency like the current COVID-19 pandemic, the FDA may issue an EUA when the agencys scientific experts have determined, among other things, that the known and potential benefits of the vaccine outweigh its known and potential risks.
For Comirnaty, the company submitted a Biologics License application (BLA) to FDA which built on the extensive data and information previously submitted that supported the EUA. This included preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections at the sites at which the vaccine is made.
FDA employees are also fathers, mothers, daughters, sons, sisters, brothers and more. They and their families are directly impacted by the work they do.
When you get a COVID-19 vaccine, you are choosing to protect yourself and make a difference for your children, parents, grandparents, and other loved ones. Millions of people in the U.S. have already received a COVID-19 vaccine. For a community to be fully protected, most community members need to get the vaccine. Getting vaccinated to prevent COVID-19 will help protect you from COVID-19, and it may also protect the people around you.
Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233 to find COVID-19 vaccine locations near you in the U.S. In some states, information may be limited while vaccination providers and pharmacies are being added. Contact your state health department to find additional vaccination locations in your area.
FDA-authorized or approved COVID-19 vaccines are distributed for free by states and local communities. You cannot buy COVID-19 vaccines online. You do not need to pay any out-of-pocket costs to get a COVID-19 vaccine not before, during, or after your appointment. If someone asks you to pay for your vaccine, it is either a scam or a mistake.
Yes. All FDA-approved and FDA-authorized COVID-19 vaccines prevent COVID-19 and serious health outcomes that COVID-19 can cause, including hospitalization and death. The FDA thoroughly evaluated and analyzed safety and effectiveness data for Comirnaty, the approved COVID-19 vaccine and those vaccines authorized for emergency use.
In evaluating requests for emergency use authorization for COVID-19 vaccines, the FDA determined that the available data provided clear evidence that the known and potential benefits outweigh the known and potential risks of each vaccine.
In evaluating the data and information included in the BLA for Comirnaty, the FDA determined that the vaccine is safe and effective and meets our rigorous standards for approval.
The available information suggests that the approved vaccine and the authorized vaccines protect the American public against COVID-19 caused by currently circulating strains of the virus that causes COVID-19.
Some variants are more contagious and spread more easily from person-to-person than the original virus that causes COVID-19. To help slow the spread of COVID-19, get a COVID-19 vaccine when it is available to you.
The FDA evaluated data from clinical studies that included tens of thousands of people for Comirnaty, the FDA-approved COVID-19 vaccine, and for each of the COVID-19 vaccines authorized for emergency use.
Authorized COVID-19 Vaccines
The FDA has authorized three vaccines for emergency use because the data from clinical studies clearly showed that the known and potential benefits of the FDA-authorized COVID-19 vaccines outweighed the known and potential risks.
Approved COVID-19 Vaccine
The data to support the decision to approve Comirnaty builds on extensive data and information that supported the Pfizer-BioNTech COVID-19 Vaccine EUA , including information about the vaccines safety and effectiveness. The safety of Comirnaty was evaluated in individuals 16 years of age and older, approximately 22,000 of whom received the vaccine and 22,000 of whom received placebo. More than half of the clinical trial participants were followed for safety follow-up for at least four months after the second dose. After issuance of the EUA, clinical trial participants were unblinded in a phased manner over a period of months to offer placebo recipients the Pfizer-BioNTech COVID-19 Vaccine. Overall, in blinded and unblinded follow-up, approximately 12,000 vaccine recipients have been followed for at least 6 months.
Allergic Reactions
Allergic reactions, including cases of anaphylaxis have happened after some people received a COVID-19 vaccine. Anaphylaxis is a severe, life-threatening allergic reaction that happens within seconds or minutes of exposure to an allergen. Because of this remote chance of severe allergic reaction or anaphylaxis, health care providers may ask you to stay at the place where you received your COVID-19 vaccine for monitoring for 15 to 30 minutes.
Myocarditis and Pericarditis Following Vaccination with Comirnaty, Moderna and Pfizer-BioNTech COVID-19 Vaccines
Post-authorization safety surveillance data pertaining to myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose of the Comirnaty, Moderna, and Pfizer-BioNTech COVID-19 vaccines. For each of these vaccines, the risk is higher in males under 40 years of age than in females or older males.
The Prescribing Information for Comirnaty and the Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers) for the Moderna and Pfizer-BioNTech COVID-19 vaccines include a warning about to the risk of myocarditis and pericarditis, and the Fact Sheet for Recipients and Caregivers includes information about myocarditis and pericarditis. The Fact Sheets for Recipients and Caregivers note that vaccine recipients should seek medical attention right away if they experience any of the following symptoms after vaccination: Chest pain Shortness of breath Feelings of having a fast-beating, fluttering, or pounding heart
Based on available information of the confirmed reported cases of myocarditis or pericarditis, most affected individuals were hospitalized and most responded well to treatment and rest, and their symptoms went away quickly.
FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months.
Guillain Barr Syndrome Following Vaccination with Janssen COVID-19 Vaccine
Guillain Barr syndrome (a neurological disorder in which the bodys immune system damages nerve cells, causing muscle weakness and sometimes paralysis) has occurred in some people who have received the Janssen COVID-19 Vaccine. In most of these people, symptoms began within 42 days following receipt of the Janssen COVID-19 Vaccine. The chance of having this occur is very low. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) includes a warning about the suggested increased risk of Guillain Barr Syndrome (GBS) and the Fact Sheet for Recipients and Caregivers includes information about GBS. The Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they experience any of the following symptoms after receiving the Janssen COVID-19 Vaccine: Weakness or tingling sensations, especially in the legs or arms, thats worsening and spreading to other parts of the body Difficulty walking Difficulty with facial movements, including speaking, chewing, or swallowing Double vision or inability to move eyes Difficulty with bladder control or bowel function
Blood Clots in Combination with Low Blood Platelets Following Vaccination with Janssen COVID-19 Vaccine
As a result of ongoing safety monitoring, on April 13, 2021, the FDA and CDC recommended a temporary pause in the use of Janssen COVID-19 Vaccine, due to reports of a serious and rare type of blood clot in combination with low blood platelets (blood cells that help your body stop bleeding). This serious condition is called thrombosis with thrombocytopenia syndrome (TTS).
On April 23, 2021, the FDA and CDC lifted the recommended pause on the Janssen COVID-19 Vaccine after this thorough safety review. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) to include a warning about the risk of blood clots with low blood platelets. The warning notes that people who developed blood clots with low blood platelets after receiving the Janssen COVID-19 Vaccine, symptoms began about 1 to 2 weeks after vaccination. Reporting of these blood clots with low levels of platelets has been highest in females ages 18 through 49 years. The Fact Sheet for Recipients and Caregivers also includes information about blood clots with low blood platelets after receiving the Janssen COVID-19 Vaccine and notes that vaccine recipients should seek medical attention right away if they experience any of the following symptoms after receiving the Janssen COVID-19 Vaccine:
These may not be all the possible side effects of Janssen COVID-19 Vaccine. Serious and unexpected side effects may occur.
The FDA is publicly sharing information about COVID-19 vaccines so you can see the evidence for yourself. The FDAs analysis of clinical trial data, including but not limited to demographic information about the clinical study volunteers, is available in the Summary Basis for Regulatory Action for Comirnaty and the decision memos that explain FDAs basis for authorizing each vaccine for emergency use. In addition, for the authorized vaccines, an FDA Briefing Document for the Vaccines and Related Biological Products Advisory Committee is available, as noted below.
Yes. The FDA and the CDChave several systems in place to continually monitor COVID-19 vaccine safety. These systems, called passive surveillance and active surveillance systems, rapidly detect and investigate potential safety problems. Systems such as the Vaccine Adverse Event Reporting System (VAERS) and CDCs text-based v-safe system, which receive reports of adverse events following vaccination, are examples of passive surveillance systems. The FDAs BEST Initiativeis an example of an active surveillance system, which analyzes information occurring in millions of individuals recorded in large data systems to investigate any safety signals that are identified by VAERS or v-safe.
Columbia University professor Jeffrey Sachs said he has disbanded a task force of scientists probing the origins of Covid-19 in favor of wider biosafety research.
Dr. Sachs, chairman of a Covid-19 commission affiliated with the Lancet scientific journals, said he closed the task force because he was concerned about its links to EcoHealth Alliance. The New York-based nonprofit has been under scrutiny from some scientists, members of Congress and other officials since 2020 for using U.S. funds for studies on bat coronaviruses with the Wuhan Institute of Virology, a research facility in the Chinese city where the first Covid-19 outbreak occurred.
A ferret in Florida tested positive for coronavirus, making it the first confirmed with COVID-19 in the United States.
The U.S. Department of Agricultures National Veterinary Services Laboratories (NVSL) said in a statement that samples were taken after the animal showed clinical signs of COVID-19, including coughing and sneezing.
The ferret is suspected to havecontracted the virus from a personwho had COVID-19.
The samples returned a presumptive positive test at the Bronson Animal Disease Diagnostic Laboratory in Florida, which was confirmed by NVSL.
Coronavirus infections have been reported in a small number of animal species worldwide, the statement said. Most of the animals had close contact with a person who had COVID-19.
According to data from the Department of Agriculture, there have been 231 confirmed positive coronavirus infections on nonfarmed animals and 17 on mink farms.
Last week, a group of African lions, two Amur tigers and a Sumatran tiger at the Smithsonian National Zoo in Washington, D.C., returned presumptive positive COVID-19 tests.
In anupdate on Friday, the zoo said that all of the tigers and three lions are eating normally and improving, while three lions are of greater concern.
According to the Centers for Disease Control and Prevention (CDC), the risk of animals spreading COVID-19 to humans is low based on available data. However,the virus can spread from people to animals in some situations.
People who test positive for COVID-19 are advised to avoid contact with animals, including pets and wildlife.
Two co-hosts of The View, Ana Navarro and Sunny Hostin, were abruptly pulled from the set on live television on Friday morning after testing positive for the coronavirus, minutes ahead of a live in-studio interview with Vice President Kamala Harris.
Joy Behar, another co-host of the show, announced that they had contracted breakthrough cases despite being fully vaccinated. None of the hosts were wearing masks on set, but members of the live studio audience were all masked.
Ana and Sunny, at the last minute, we realized they tested positive for Covid, Ms. Behar said. Ms. Harris, who was in the building preparing to come onstage, later appeared remotely on the program from another room. But her appearance was truncated.
I know theyre fine, but it really does speak to the fact that theyre vaccinated and vaccines really make all the difference, because otherwise wed be concerned about hospitalization and worse, Ms. Harris said, speaking from a remote studio with what appeared to be an iPhone headphone on her ear.
After the positive cases were announced, Ms. Behar and another co-host, Sara Haines, were the only hosts left on set (Whoopi Goldberg, another host, was off on Friday). They took questions from the audience to fill the program while the Secret Service tried to find a way for Ms. Harris to safely participate in the planned interview.
The announcement of the positive cases came minutes after the hosts had been discussing the importance of getting vaccinated and after they had promoted Ms. Harris appearance as her first in-studio interview since taking office.
Ms. Harris appearance on The View had long been planned and was one of only a handful of television interviews she has participated in since taking office. But the timing was not ideal for a vice president whose portfolio includes immigration issues, but who had hoped to use the opportunity to make an announcement about a new broadband investment set to reach more than 3 million schoolchildren.
It came as the administrations handling of Haitian migrants at the border prompted outrage among Democrats and called into question President Bidens decision to swiftly deport thousands who had been arriving en masse at a small Texas border town.
Critics have called the aggressive tactics of Border Patrol racist and have urged the president to stop flying the Haitians out of the country.
During her appearance on Friday, Ms. Harris acknowledged that the images of Border Patrol agents on horseback, some waving their reins while pushing migrants back into the Rio Grande, evoked images of some of the worst moments of our history, where that kind of behavior has been used against the Indigenous people of our country, has been used against African Americans during times of slavery.
But she avoided a question about whether the administration would halt all deportation of Haitians at the Texas border and allow them to apply for asylum.
We have to do more in supporting Haitians who are returning to the island, returning to Haiti, Ms. Harris said. We have got to do more to support Haiti in terms of its needs to get back up and recover, in terms of the natural disasters.
She also noted that the Haitian government is still in disarray and in the process of rebuilding after the president was assassinated. As a neighbor, the U.S. has to help, she said.
A spokeswoman for the vice president, Sabrina Singh, said in a statement that Ms. Harris had no contact with the hosts before the show and that her schedule today will continue as planned.
A spokeswoman for The View did not immediately respond to a request for comment about why the co-hosts received their test results only after appearing on set.
(Bloomberg) -- Erica Ollmann Saphire spent the past year and a half profiling the coronavirus, creating intricate three-dimensional images in her San Diego lab to understand its most problematic features. That information is now revealing the pathogens weak spots and ways to exploit them.
Using an 11-foot (3.35 meter) tall microscope, the most powerful commercially available, shes scoured hundreds of different antibodies against the Covid culprit to identify its salient features. The research at the La Jolla Institute of Immunology led to a study Thursday in Science that gives the most detailed map yet of how to circumvent the SARS-CoV-2 viruss panoply of mutations and variants.
The map, produced in collaboration with 56 research groups on four continents, is enabling scientists to devise blueprints for better vaccines and treatments to thwart the hyper-infectious delta strain, which has become dominant globally, and its successors.
We now have a framework for selecting durable antibody cocktails for Covid-19 treatment, said Ollmann Saphire, who is president and chief executive officer at the La Jolla Institute.
The aim is find two potent and complimentary antibodies that can be combined into a $25 therapy for Covid-19 patients who havent been vaccinated, couldnt be vaccinated, or have developed a breakthrough infection.
Were probably a long way from $25, but the goal is to bring it down from $1,000 to something that could treat more people, she said in a Zoom call Friday. To be practically useful, its got to be something thats durable and resistant to the variants that are circulating.
The World Health Organization on Friday recommended a combination of neutralizing monoclonal antibodies -- casirivimab and imdevimab -- developed by Regeneron Pharmaceuticals Inc. for treating Covid patients at the highest risk of severe disease, and urged drugmakers and governments to address the high price and limited production of the medication.
One rock star antibody developed by a collaborating lab is so far outperforming more than 350 other candidates analyzed by the Coronavirus Immunotherapy Consortium that Ollmann Saphire is leading. Its been shown to block immune-evading variants and provide 100% protection against Covid-19 in lab mice.
I have my eye on that one, and Im looking to see what we might want to pair with it to take forward into clinical studies, she said.
Research on mice is also pointing to a more potent approach to vaccine development based on a more stable version of the coronaviruss spike protein made in her lab that could be used by new or existing inoculations against SARS-CoV-2.
Its fantastic, Ollmann Saphire said. We can make gobs of it and it stays in the right shape and structure for a month in a drawer in the lab at room temperature.
2021 Bloomberg L.P.
DENVER (KDVR/WATE) Fall is officially here and with it, comes seasonal allergies. From coughing, to sneezing, and even that scratchy throat, how can you tell the difference between your allergies and COVID-19?
The answer might not be as simple as it seems. The easiest way to determine the difference is by getting a COVID-19 test.
According to Dr. Flavia Hoyte, an allergist with National Jewish Health, Most people who have allergies know what their allergies feel like and when they tend to peak.
A fever does not accompany allergies, so if you have one it could be the first sign that you may want to get tested for COVID-19. Experts warn that you can also be sick with COVID-19 and not have a fever, however.
As we enter the fall, parents bracing themselves for the usual cold and flu threats now have to be on the look out for COVID-19 and spiking RSV cases in parts of the country.
Its really challenging for parents to tell the difference between seasonal allergies, common colds, and potentially the COVID virus and how its affecting kids, East Tennessee Childrens Hospitals Chief Medical Officer, Dr. Joe Childs, told WATE. Symptoms between RSV and other viruses, even COVID, are almost identical.
Dr. Childs said COVID-19 and RSV case numbers are remaining high, were seeing all these other respiratory viruses were used to seeing in the winter right now because over the course of the winter we just didnt see it. With people being much more separate, no worldwide travel, masks being used a lot more, it just protected us from having that kind of season while we were protecting ourselves against COVID-19.
Now, the changing of seasons has some people concerned about whether their sniffles are from fall allergies or something more severe.
As the fall pollen season starts, which is especially weeds that are pollinating right now, if you are especially sensitive avoid being outside as much as possible until your past that pollination period, Childs said.
As a first step toward protecting yourself and your children, Childs recommends testing when someone in the immediate family falls ill.
Childs said social distancing, masking, and washing your hands are always the best practices to keeping from getting sick, but if you do come down with a cough, Anytime a family member is ill with respiratory symptoms, they need to avoid close contact with the very youngest of children.
He adds that right now is the best time to get your COVID-19 vaccine if you havent gotten it already, but getting your flu shot can wait. The protection you want from the flu vaccine, it would be best to wait until its closer to when the flu is going to arrive here to get that protection.
Lastly, he says if you feel sick, your first call should be to your primary care provider. Doctors say when it comes to allergies, antihistamines can be very effective.Monoclonal antibody infusionsare also effective for people who find themselves with COVID-19, are at high risk, and older than 12.
These are the common symptoms of allergies, according to National Jewish Health:
Some allergy symptoms, like nasal congestion or runny nose, also can be symptoms of viral infections such as a cold or COVID-19.
Allergies generally will not affect the lungs, but can trigger asthma in people with allergic asthma. Allergies also typically do not cause a fever or extreme fatigue, according to the National Jewish Health.
According to the World Health Organization, the most common symptoms of COVID-19 are:
Other symptoms that are less common and may affect some patients include:
Symptoms of severe COVID19 disease include:
Other less common symptoms are:
This list does not include all possible symptoms.
Four more Mainers have died as health officials on Saturday reported another 603coronavirus cases across the state.
Saturdays report brings the total number of coronavirus cases in Maine to 87,189,according to the Maine Center for Disease Control and Prevention. Thats up from 86,586 on Friday.
Of those, 62,365have been confirmed positive, while 24,824were classified as probable cases, the Maine CDC reported.
Two men and two women in their 60s and 70s from Aroostook, Cumberland, Kennebec and Oxford counties have succumbed to the virus, bringing the statewide death toll to 1,013.
The number of coronavirus cases diagnosed in the past 14 days statewide is 6,679. This is an estimation of the current number of active cases in the state, as the Maine CDC is no longer tracking recoveries for all patients. Thats up from 6,657 on Friday.
The new case rate statewide Saturday was 4.51 cases per 10,000 residents, and the total case rate statewide was 651.44.
Maines seven-day average for new coronavirus cases is 470.1, up from 465.9 the day before, down from 485.3 a week ago and up from 174.1 a month ago. That average peaked on Jan. 14 at 625.3.
The most cases have been detected in Mainers younger than 20, while Mainers over 80 years old make up the majority of deaths. More cases and deaths have been recorded in women than men.
So far, 2,454 Mainers have been hospitalized at some point with COVID-19, the illness caused by the new coronavirus. Of those, 235 are currently hospitalized, with 84 in critical care and 36 on a ventilator. Overall, 42 out of 341 critical care beds and 185 out of 299 ventilators are available.
The total statewide hospitalization rate on Saturday was 18.34 patients per 10,000 residents.
Cases have been reported in Androscoggin (9,488), Aroostook (3,160), Cumberland (19,827), Franklin (1,759), Hancock (2,106), Kennebec (8,118), Knox (1,576), Lincoln (1,504), Oxford (4,289), Penobscot (9,980), Piscataquis (1,033), Sagadahoc (1,690), Somerset (3,340), Waldo (2,008), Washington (1,307) and York (16,004) counties.
An additional 1,386 vaccine doses were administered in the previous 24 hours. As of Saturday, 867,995 Mainers are fully vaccinated, or about 73.3 percent of eligible Mainers, according to the Maine CDC.
New Hampshire reported 744 new cases on Saturday and three deaths. Vermont reported 242 new cases and three deaths, while Massachusetts reported 1,920 new cases and 14 deaths.
As of Saturday afternoon, the coronavirus had sickened 42,874,839 people in all 50 states, the District of Columbia, Puerto Rico, Guam, the Northern Mariana Islands and the U.S. Virgin Islands, as well as caused 687,572 deaths, according to the Johns Hopkins University of Medicine.
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Illinois health officials on Friday reported 21,787 new COVID-19 cases in the past week, along with 239additional deaths and over 135,000 new vaccine doses administered.
In all, 1,612,129 cases of coronavirus have been reported in the state since the pandemic began, according to the latest data from the Illinois Department of Public Health. The additional deaths reported this week bring the state to 24,783 confirmed COVID fatalities.
The state has administered 797,018 tests since last Friday, officials said, bringing the total to more than 31 million tests conducted during the pandemic.
The states seven-day positivity rate on all tests dropped to 2.7% from last week 4.4% and 4.5% the week before, officials said. The rolling average seven-day positivity rate for cases as a percentage of total tests also dropped to 3.7% from 4.1% last week and 5.1% the week before.
Over the past seven days, a total of 135,598doses of the coronavirus vaccine have been administered to Illinois residents. The latest figures brought the states average down to 19,371 daily vaccination doses over the last week, per IDPH data.
More than 14.4 million vaccine doses have been administered in Illinois since vaccinations began in December. More than 63% of adult residents in the state are fully vaccinated against COVID-19, with more than 80% receiving at least one dose.
As of midnight Thursday, 1,926 patients were hospitalized due to COVID in the state. Of those patients, 474are in ICU beds, and 252are on ventilators.
This week in coronavirus: Infections are finally falling. Deaths are not. The Tennessean
