Q: At The Time Of Authorization What Information Was Available About Serious Adverse Events That Occurred During The Clinical Trial In Individuals 16 Years Of Age And Older
A: Serious adverse events, while uncommon , were observed at slightly higher numerical rates in the vaccine study group compared to the saline placebo study group, both overall and for certain specific adverse events occurring in very small numbers. These represented common medical events that occur in the general population at similar frequency. Upon further review by the FDA, these imbalances do not raise a safety concern, nor do they suggest a causal relationship to vaccination for the vast majority of reported serious adverse events.
Serious adverse events considered by the FDA to be plausibly related to the vaccine or vaccination procedure were one case of shoulder injury at the vaccination site and one case of swollen lymph node in the armpit opposite the vaccination arm.
No safety concerns were identified in subgroup analyses by age, race, ethnicity, medical comorbidities, or prior SARS-CoV-2 infection.;
What Are The Known Side Effects Of The Covid Vaccines
In general, side effects are not uncommon with vaccines, and the COVID-19 shot is no exception. Your bodys immune reaction could include the same kinds of side effects often seen with other vaccines, including a sore arm, fatigue, fever, chills or headaches.
This is expected, Dr. Neeta Ogden, an internal medicine specialist and immunologist, said in an interview on CBSN.
People should maybe think about vaccinating on weekends, for example, she said. You probably might need to take a day off from work. This is predictable and I dont think that it is alarming.
Not everyone experiences side effects, but doctors stress that their occurrence is;normal and should not discourage people from getting the shots.;
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Do I Need To Get Vaccinated If Ive Already Had Covid
Even after youve gotten sick from COVID-19 and recovered, you could still get it again. So-called natural immunity varies from person to person. The vaccines, on the other hand, provide a reliably high level of protection.
That said: If you were treated with monoclonal antibodies or convalescent plasma during your illness, you should wait 90 days before getting a COVID-19 vaccine. The CDC also recommends you should talk to your doctor before proceeding.
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Will The Vaccine Work If Ive Already Had Covid
The U.S. Centers for Disease Control and Prevention notes that people who have already had COVID-19 or tested positive may still benefit from getting the COVID-19 vaccination. There is not enough information currently available to say if or for how long people are protected from getting COVID-19 after they have had it . Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this.
How Long Does Immunity Last After Covid
Millions of doses of COVID-19 vaccines are being delivered across the world, but what do we know about how long will immunity last?
Now that we are getting over the first hurdle of vaccine delivery and millions of people around the world have been vaccinated against COVID-19, the big question now is how long that immunity will last.
Several COVID-19 vaccines have been now been granted emergency use authorisation, having demonstrated that they are both safe and effective. But when new vaccines are developed, it is only through ongoing wide-scale use that we can better understand their ability to prevent transmission and the duration of immunity. Because of this, it has been too soon to say exactly how long these COVID-19 vaccines will protect people for, and whether we might need a booster shot further down the line. However, now the first evidence is emerging
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What Are Breakthrough Infections And Why Do They Happen
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.
Can We Extrapolate From What We Know About Natural Immunity
In fact, much of this hypothesizing comes from extrapolating data examining immune responses in people who have had covid-19 and illnesses from other coronaviruses, rather than in people who have been vaccinated, said Dbeibo, who is director of vaccine initiatives for Indiana University.
But vaccine responses should not be less reliable than in natural infection, she added.
Current research shows that people who have been infected with covid-19, the illness caused by the coronavirus, retained immunity that was robust after eight months. That gives researchers a starting point in predicting how long immunity may last after vaccination, Dbeibo explained.
But research also shows people who had more severe cases developed a stronger immune reaction than those with milder forms of the disease. And because vaccine-induced immunity appears to be more similar to natural immunity that is derived from severe covid-19 infections, researchers say they believe people who take a coronavirus vaccine will be protected better than most people with natural immunity, said David Topham, a professor of microbiology and immunology at the University of Rochester.
He said memory B cells can even adapt quickly to a new variant, usually within days.
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What’s A Booster Shot And When Can I Get One
A “booster” refers to an extra dose for those whose immune systems responded well to the initial vaccines but might face waning efficacy as time goes on.
Pharmacies began offering third doses to fully vaccinated,;immunocompromised patients in August 2021. Roughly 10 million people in the U.S. may qualify for such additional shots, with roughly 3% of Americans estimated to be immunocompromised.
Pharmacy chains expect the FDA to authorize boosters for the general over-12 population as soon as September 2021.;
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Frequently Asked Questions About Covid
NOTICE: FDA has granted full approvalfor Pfizer-BioNTech COVID-19 Vaccine. CDCs Advisory Committee on Immunization Practices is meeting on Monday, August 30, 2021, to discuss its updated recommendation for this vaccine.
- Below are answers to commonly asked questions about COVID-19 vaccination.
- Bust myths and learn the facts about COVID-19 vaccines
If you have lost your vaccination card or dont have a copy, contact your vaccination provider site where you received your vaccine to access your vaccination record. Learn more;about how you can locate your vaccination provider.
Yes, you should be vaccinated regardless of whether you already had COVID-19 because:
- Research has not yet shown how long you are protected from getting COVID-19 again after you recover from COVID-19.
- Vaccination helps protect you even if youve already had COVID-19.
Evidence is emerging that people get better protection by being fully vaccinated compared with having had COVID-19. One study showed that unvaccinated people who already had COVID-19 are more than 2 times as likely than fully vaccinated people to get COVID-19 again.
If you were treated for COVID-19 with monoclonal antibodies or convalescent plasma, you should wait 90 days before getting a COVID-19 vaccine. Talk to your doctor if you are unsure what treatments you received or if you have more questions about getting a COVID-19 vaccine.
When Does It Start Working
After receiving a COVID-19 vaccine, it takes weeks for your immunity to build. According to the CDC, full protection occurs two weeks after the second dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines, or two weeks after the single-dose Johnson & Johnson vaccine.
Although it takes a second dose to reach full protection for the Pfizer-BioNTech and Moderna vaccines, data suggests that a significant immune response occurs about two weeks after the first dose. For example, an FDA briefing document for Moderna’s emergency use authorization application listed an overall efficacy of 50.8% between days one to 14 and an efficacy of 92.1% occurring after 14 days for one dose.
A CDC report that tracked almost 4,000 healthcare personnel, first responders, and other frontline workers under real-world conditions found that the mRNA vaccines were 80% effective at least 14 days following the first dose and 90% effective at least two weeks after the second dose.
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What You Need To Know
- COVID-19 vaccines are effective at helping protect against severe disease and death from variants;of the virus that causes COVID-19 currently circulating, including the Delta variant.
- If you are fully vaccinated you can resume many activities that you did before the pandemic, but you should wear a mask indoors in public;if you are in an area;of substantial or high transmission;to maximize protection from the Delta variant and possibly spreading it to others.
- You may have;side effects;after vaccination. These are normal and should go away in a few days.
- Learn how to find a COVID-19 vaccine;so you can get it as soon as you can.
I Got A Mild Breakthrough Case Heres What I Wish Id Known
Hipps never ran a fever, though, and did not have bad head or body aches. She started feeling better after about a week, tested negative and went back to working from home and caring for her family. She thought she was fully recovered.
And I was in my moms new car and all of a sudden I felt burning. And I thought there was something wrong with her car, she says.
Wherever she moved her foot, she could still feel the burning sensation. And then her other foot started burning too. It felt like she was walking on hot coals, she says.
Ive learned that this is neuropathy, and this a common symptom of long COVID, Hipps says.
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Vaccine Protection And Infection
Vaccines can stop most people from getting sick with COVID-19, but not everyone.
Even after someone takes all of the recommended doses and waits a few weeks for immunity to build up, there is still a chance that they can get infected. Vaccines do not provide full protection, so breakthrough infections where people get the virus, despite having been fully vaccinated will occur.;
If vaccinated people do get sick, they are likely to have milder symptoms, in general ‘It is very rare for someone vaccinated to experience severe illness or die.
Can I Spread It To Others And Do I Need To Quarantine
Unfortunately, you still have COVID and need to act like it.
Even though my first two tests were negative, I started wearing a mask at my house and keeping my distance from my vaccinated family members. Im glad I did: no one else got sick.
The delta variant is more than two times as contagious as the original strain of the virus and can build up very quickly in your upper respiratory tract, as was shown in a cluster of breakthrough infections linked to Provincetown, Mass. over the summer.
Even in fully vaccinated, asymptomatic individuals, they can have enough virus to transmit it, says Dr. Robert Darnell, a physician scientist at The Rockefeller University. Delta is very good at replicating, attaching, and inserting itself into cells.
The science isnt settled about just how likely vaccinated people are to actually spread the virus, and it does appear that the amount of virus in the nose decreases faster in people who are vaccinated.
Even so, wearing masks and staying isolated from others if you test positive or have symptoms is absolutely critical, Darnell says. He also advises getting tested if you are exposed to someone who has COVID, even if youve been vaccinated, because you could very well get infected or ill, and you want to protect those around you, including all the children who arent vaccinated.
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How To Assess Risk
Dr. Meyer welcomes the above guidance from the CDCespecially compared to what things were like a year ago.; ;
Last year at this time, we were in a huge data vacuum. We were telling people that everything they did required a risk assessment for themselves and anyone they came in contact with, which became very confusing, Dr. Meyer says. Now, we understand much more about how the virus is transmitted, and we have safe and effective vaccines at our disposal. This means people who have been vaccinated can take a deep sigh of relief. ;
Plus, most public places now have many safety precautions in place, and as more people get vaccinated and case rates eventually go down, our worlds will become even safer, Dr. Meyer says.; ;
The first thing I did when I was fully immunized… I jumped in my car and drove to Vermont to see my baby nephew and my sister, who I hadnt seen in a year. It was wonderful, says Dr. Meyer.
There is still a risk assessment, but its easier, she adds. If you are fully vaccinated, there is minimal risk of becoming severely ill with COVID-19, Dr. Meyer says.;
Plus, every day we learn more about the virus variants, and those should be a part of your risk calculation, too, she adds. Some, like the B.1.1.7 variant , are more contagious and potentially more lethal, she says. To date, though, the available vaccines appear to be effective at preventing severe disease even in cases that involve that variant. ;
Should I Get The Covid
New research suggests that people who have already gotten sick with COVID-19 benefit from the vaccine, possibly even more than vaccinated people who were not previously infected.
A study published in NEJM found that people who were previously infected with SARS-CoV-2 and then received a single dose of either mRNA vaccine experienced a rapid immune response and generated at least as many, or more, antibodies as previously uninfected people who had received two doses of vaccine.
And a study published in Science compared the effects of the Pfizer vaccine in people with and without prior infection. The researchers found that previously infected people who were vaccinated had a stronger immune response against the B.1.1.7 and B.1.351 variants than previously uninfected people who were vaccinated.
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Vaccine Immunity Vs Immunity From Covid
Another reason to cheer: COVID-19 vaccines actually induce higher levels of antibodies than natural infection, says John Wherry, director of the Institute for Immunology at the University of Pennsylvania.
Early on, looking at people who had recovered from COVID, there were studies that showed antibodies may wane quickly after acute infection, he says. What we eventually realized is that antibodies naturally go up, they come down, and then they settle into a steady state. More recent studies indicate that people whove had COVID-19 have good antibody and other immune memory for at least eight to nine months, which was as long as could be analyzed this far into the pandemic.
Since people whove been vaccinated mount an even better immune response, Wherry says he thinks immunity from the COVID-19 vaccines will likely last several years, if not longer. He notes that scientists will need to be on alert for canaries in the coal mine that indicate immunity may be waning, particularly in certain populations, like those over 65 or people with compromised immune systems.
We have to monitor these things and plan accordingly, and be ready to make decisions if we start to see emergence of new infections, he says.
The Fda Has Granted Full Approval To The Pfizer/biontech Covid
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 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.”
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