Q: What Safety And Effectiveness Data Did Fda Evaluate To Support The Authorization For Emergency Use Of Administration Of A Single Vaccine Booster Dose
A: FDA analyzed safety and immune response data from a subset of participants from the original clinical trial of the Pfizer-BioNTech COVID-19 Vaccine. The immune responses of approximately 200 participants 18 through 55 years of age who received a single vaccine booster dose approximately 6 months after their second dose were assessed. The antibody response against a Wuhan-like SARS-CoV-2 virus one month after a booster dose of the vaccine compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.
Safety was evaluated in 306 participants 18 through 55 years of age and 12 participants 65 years of age and older who were followed for an average of over two months. The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after primary series doses.
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In December, Pfizer announced that two doses of the vaccine in children under 5 had not generated the same level of antibodies as was seen after two doses in people 16 to 25, which was being used as a proxy for protection. It said it would give the children under 5 a third dose to see if that achieved the required level of protection.
But then as Omicron cases spiked across the country, the Food and Drug Administration revealed it was considering a rolling authorization for the vaccine for children under age 5, allowing parents to start vaccinating their children while waiting for the third dose. The rationale was that the risk-benefit equation had shifted with Omicron.
A meeting of the FDAs vaccine advisers, the Vaccines and Related Biological Products Advisory Committee, was scheduled for mid-February. But before the group could meet the FDA and Pfizer announced the plan was on hold. The plan is now to wait for the third-dose results before considering authorization in this age group.
Will I Need A Third Booster Soon
At this point, no one knows if or when the FDA might authorize an additional booster dose for those who have already received two.
Early trials of omicron-specific boosters are still underway, so it’s not yet known whether those would offer an advantage over the first-generation boosters. While we await the results of those trials, more data should emerge about the benefits of the second booster doses in different populations.
Recentstudies hint that, in general, the second booster dose may not offer as dramatic a bump in antibodies or as significant an increase in immune memory compared with the first booster dose. In general, this might hint that repeated booster doses may offer “diminishing results,” The New York Times reported.
“From what we know so far, the third dose is likely to be the most important,” Moore said, referencing the first mRNA booster. This first booster follows a key period of time where the immune system consolidates its memory of the virus and establishes immune cell training camps known as “germinal centers,” according to Nature. The booster likely helps to cement this immunological memory while also broadening which features of the virus can be recognized by the immune system.
So will a third booster someday be necessary? For now, we don’t know and of course, the emergence of a new SARS-CoV-2 variant could complicate the question.
Originally published on Live Science.
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Q: After The Fda Granted The Emergency Use Authorization Of The Pfizer Biontech Covid
A: Yes. After issuance of the EUA, clinical trial participants were unblinded in a phased manner over a period of months to offer the authorized Pfizer-BioNTech COVID-19 Vaccine to placebo participants. These participants were followed for safety outcomes. Overall, in blinded and unblinded follow-up, approximately 12,000 Pfizer-BioNTech COVID-19 Vaccine recipients have been followed for at least 6 months.
Pfizer Shot Is Far Less Effective In 5
While protection against hospitalization is still strong, the vaccine offered almost no protection against infection, even just a month after full vaccination.
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The coronavirus vaccine made by Pfizer-BioNTech is much less effective in preventing infection in children ages 5 to 11 years than in older adolescents or adults, according to a large new set of data collected by health officials in New York State a finding that has deep ramifications for these children and their parents.
The Pfizer vaccine is the only Covid shot authorized for that age group in the United States. It still prevents severe illness in the children, but offers virtually no protection against infection, even within a month after full immunization, the data, which were collected during the Omicron surge, suggest.
The sharp drop in the vaccines performance in young children may stem from the fact that they receive one-third the dose given to older children and adults, researchers and federal officials who have reviewed the data said.
The findings, which were posted online on Monday, come on the heels of clinical trial results indicating that the vaccine fared poorly in children aged 2 to 4 years, who received an even smaller dose.
Still, he and other public health experts said they recommend the shot for children given the protection against severe disease shown even in the new data set.
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Efficacy Across Different Groups
A consistently high efficacy was observed in the clinical trials across age groups, sex, race, ethnicity and people with underlying medical conditions.
This means after getting two doses of the Pfizer vaccine, more than 9 out of 10 people are protected against COVID-19 regardless of their age, health status or ethnic group.
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The state recorded more than 850,000 Covid cases in adolescents aged 12 to 17 during that time, and about 365,000 in children aged 5 to 11.
Over that period, two-dose vaccine protection against infection for kids aged 5 to 11 declined from 68% to 12% the vaccines effectiveness at preventing hospitalization declined from 100% to 48%.
But two-dose protection against infection for children aged 12 to 17 only dropped from 66% to 51%, and protection against hospitalization from 85% to 73%.
Our data support vaccine protection against severe disease among children 5-11 years, but suggest rapid loss of protection against infection, in the Omicron variant era, the researchers wrote. Should such findings be replicated in other settings, review of the dosing schedule for children 5-11 years appears prudent.
The adult Pfizer regimen used in anyone aged 12 and older is two doses of 30 micrograms apiece, given 21 days apart. Children 5 to 11 years old receive a dose that is one-third that size, two doses of 10 micrograms apiece. And in studies of children under 5, the dose is further reduced, with the children aged 6 months to 4 years getting two 3-microgram doses. The vaccine is not yet authorized for use in children under 5.
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What We Know About Immunity After Vaccination Booster Shots And Protection Against New Variants
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Clinical trials and real-world conditions have proved that vaccines protect against COVID-19. But the question remains: How long will vaccine immunity last?
In light of the Omicron variant now the most dominant variant in the United States the Centers for Disease Control and Prevention strongly recommends everyone 5 years and older get vaccinated. And if it has been five months since your last Pfizer or Moderna vaccine or two months since your Johnson & Johnson vaccine, getting a booster shot is recommended for those 12 and older.
Dr. Sharon Chacko
To learn more about this evolving issue, Health Matters spoke with Dr. Sharon Chacko, medical director of COVID-19 immunizations in the Division of Community and Population Health and an assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons, about vaccine immunity and the recommendation for booster shots amid Omicron.
With Omicron, many more people have experienced breakthrough infections. Does that mean vaccines arent working?While Omicron is more transmissible and is responsible for more breakthrough infections than any other variant, a breakthrough infection doesnt mean that the vaccine isnt working. In fact, for most people who are vaccinated and boosted, the symptoms are typically very mild. This emphasizes the importance of vaccination and boosters to prevent severe illness and hospitalizations.
Does Testing Positive For Covid
Unfortunately, no. Experts dont know whether a positive COVID-19 antibody test means that a person is or will become immune to the COVID-19 virus. As mentioned above, some people dont become immune after being sick. These people may still make antibodies while theyre sick. But their immune systems dont remember how to fight the infection after they get better.
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Is It Ok To Get The Covid
While there have been reports of severe allergic-type reactions in a very small number of patients, the CDC says that people with allergies to certain foods, drugs, insects, latex and other common allergens can still get the COVID-19 vaccine.
If you have had a severe allergic reaction to injectables or other vaccines, be sure to discuss the COVID-19 vaccination with your doctor, who can evaluate you and assess your risk. The vaccine provider should observe you for 30 minutes rather than the routine 15 minutes after vaccination, and if you have an allergic reaction to the first shot, you may not receive the second.
The CDC says that at this time, anyone who has a severe allergy to any of the vaccine ingredients should not get that vaccine.
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What Are The Benefits Of The Booster
The FDA justified its authorization of second booster shots based on several studies conducted in Israel.
One study, posted Feb. 1 to the preprint database medRxiv, included more than a million people age 60 or older who had either received one booster shot or two. The follow-up time was very short only 12 days but suggested that the rate of severe disease was about four-fold lower in the double-boosted group, Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, California, wrote in a blog post last week.
Another study from Israel, posted on March 24 to Nature’s preprint database, included more than 560,000 people ages 60 and older, and showed that those who received a second booster had a 78% lower death rate from COVID-19 compared with those who only received one booster.
But how long this boost in protection lasts is an open question.
“The deficiency in our knowledge base is the lack of follow-up, maximal at only 40 days so far, for enhanced protection vs. severe illness, hospitalization and death,” Topol noted in his blog.
As these people are followed over time, we should know how long the enhanced protection lasts and there should also be more data on younger people available soon, he noted.
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How Long Will Immunity Last
According to Pfizer, initial results based on Phase 3 clinical trials in adults found the vaccine was:
- 100% effective in preventing severe disease
- 95% effective in preventing severe disease
- 91% effective in providing immunity against COVID-19 for six months
A November 2021 update focused on how effective the vaccine was in people ages 12 to 15. These results showed the vaccine was 100% effective against COVID-19.
Further research on the Pfizer vaccine, also known as Comirnaty, supports its effectiveness. A November 2021 research review of studies on nine different COVID-19 vaccines developed around the world found that overall, the Pfizer and Moderna vaccines performed better than alternatives in preventing symptomatic disease.
Can I Still Get Covid
Because no vaccine is 100 percent effective, breakthrough infections may occur. But experts stress that the vaccines remain highly protective against hospitalization and death if you do catch COVID.
Breakthrough infections, however, can contribute to the spread of COVID-19. New data show that fully vaccinated people who become infected with the highly transmissible delta variant can pass the virus on to others, which is why health officials now recommend that vaccinated individuals in areas of high community transmission wear a face mask in indoor public settings.
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Covid Vaccine Immunity Is Waning How Much Does That Matter
For those vaccinated against COVID-19, antibody levels eventually wane, but this is not the whole story.Credit: Kateryna Kon/Science Photo Library
Six months ago, Miles Davenport and his colleagues made a bold prediction. On the basis of published results from vaccine trials and other data sources, they estimated that people immunized against COVID-19 would lose approximately half of their defensive antibodies every 108 days or so. As a result, vaccines that initially offered, say, 90% protection against mild cases of disease might only be 70% effective after 6 or 7 months.
It felt a little bit out on a limb at the time, says Davenport, a computational immunologist at the University of New South Wales in Sydney, Australia. But on the whole, his groups predictions have come true.
Immunological studies have documented a steady decline of antibody levels among vaccinated individuals. Long-term follow-up of vaccine trial participants has revealed a growing risk of breakthrough infection. And health-care records from countries such as Israel, the United Kingdom and elsewhere all show that COVID-19 vaccines are losing their strength, at least when it comes to keeping a lid on transmissible disease.
How Effective Is The Covid
As with any vaccine, the Pfizer vaccine may not fully protect everyone who gets it. However, it is highly effective if people have both doses. That means, if you do catch COVID-19, youre far less likely to fall seriously ill and less likely to transmit the virus to others.
The COVID-19 vaccine stimulates your bodys immune system to produce antibodies and other proteins that will fight the virus if youre exposed to it. This reduces the risk of getting infected and if you do get COVID-19, it means you could have no symptoms or will have much fewer, milder symptoms and recover faster.
While the data is clear that vaccines protect people from the effects of COVID-19, research is ongoing to determine whether a vaccinated person could still transmit the virus to someone else so to be safe, we must assume there is still a risk of transmission.
The point of the vaccine is it dramatically reduces your risk of getting COVID-19, absolutely.
If you have been vaccinated, even with the Delta variant youve got more than 90% chance of not ending up in hospital, not being in intensive care and not dying. So thats pretty bloody good odds.
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Are There Any Safety Risks
The available data suggest that second booster shots don’t come with any notable safety concerns, according to the FDA.
The Ministry of Health of Israel sent the FDA a summary of safety surveillance data collected from about 700,000 people mostly over age 60 who received second booster doses of the Pfizer-BioNTech vaccine at least four months after their first booster doses. This analysis “revealed no new safety concerns,” the FDA noted.
The safety of the Moderna second booster was “informed by experience with the Pfizer-BioNTech COVID-19 vaccine and safety information reported from an independently conducted study,” the FDA said. This small study included 120 adult participants who received a first booster dose of Pfizer-BioNTech and then a second booster of Moderna. “No new safety concerns were reported during up to three weeks of follow up after the second booster dose,” the FDA said.
Is There A Vaccine For The Coronavirus Disease
Several COVID-19 vaccines have been authorized for emergency use among specific age groups by the U.S. Food and Drug Administration . Johns Hopkins Medicine views all authorized COVID-19 vaccines as highly effective at preventing serious disease, hospitalization, and death from COVID-19.
Learn more about coronavirus vaccine safety.
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Do You Still Need To Take Precautions After Being Vaccinated
If youve received both doses of the vaccine, its important to still continue to take precautions, including:
- Wearing a mask.Wear a mask that covers your nose and mouth when youre around people outside of your household.
- Hand-washing.Hand-washing is particularly important after being out in public, after coughing and sneezing, and after using the bathroom.
- Practicing physical distancing. Try to stay at least 6 feet away from people outside of your household.
- Avoiding crowded areas. Places that are crowded or poorly ventilated can make it easier to contract and transmit the virus.
These precautions are important because we currently dont know whether people whove been vaccinated can still spread the virus to others, even if they themselves dont develop symptoms.