What Role Do Trials Have
If the safety data from the labs is good, scientists can check the vaccine or treatment is effective.
That means tests on large numbers of volunteers – about 40,000 in the case of Pfizer-BioNTech, the first to be approved in the UK.
Half are given the vaccine and the other half a placebo jab. The researchers and participants are not told which group is which, until after the results, to avoid bias.
All of the work and findings are checked and verified independently.
The Covid vaccine trials happened at breakneck speed, but they didn’t skip any steps – they were able to move faster because so many people were involved and other projects were put aside.
The Vaccines Only Are Authorized For Emergency Use It Makes Me Uncomfortable That They Dont Have Full Fda Approval
The clinical trials already were complete by the time the vaccines received Emergency Use Authorization, Dr. DSouza said. The road to full approval is paved with paperwork.
They have to put all the paper trail in place, and its really the paperwork thats causing the delay, he said. And that takes forever, as you can imagine, a vaccine trial with so many multi-centers, people are just scattered in different parts of the country and around the world.
All of that information now has to be tabulated. It has to be put into place, documented, and thats when the final approval will come through.
The initial submission to the FDA essentially stands, he said.
Most of the data that was available at the emergency time is whats being used for the full approval, he said. If there were any adverse effects, those have been added into the full approval process.
The FDA is expected to give full authorization to the Pfizer vaccine by late summer or early fall.
Takeaway: Reviewing and filing documents is time consuming, but full authorization for at least one COVID-19 vaccine is expected soon.
Who Can Get A Third Dose Of A Covid
Based on CDC recommendations, third vaccine doses are available now for people who are considered moderately or severely immunosuppressed. These would include those who:
- Receive active cancer treatment for tumors or cancers of the blood.
- Received an organ transplant and are taking medicine to suppress the immune system.
- Have either had a stem cell transplant within the last two years or are taking medicine to suppress the immune system.
- Were diagnosed with DiGeorge syndrome or Wiskott-Aldrich syndrome.
- Are diagnosed with HIV and have a high viral load or low CD4 count, or are not currently taking medication to treat HIV.
- Are taking drugs such as high-dose steroids or other medications that may cause severe suppression of the immune system.
If you are not sure whether you fit into any of these categories, please contact your medical provider.
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Three Things To Know About The Long
Many Americans say they want to make sure the shot is safe before getting vaccinated. That data is already in, and it is overwhelming.;
Many Americans say they want to make sure the shot is safe before getting vaccinated. That data is already in, and it is overwhelming. In his nearly 30 years studying vaccines, Paul Goepfert, M.D., director of the Alabama Vaccine Research Clinic at the;University of Alabama at Birmingham, has never seen any vaccine as effective as the three COVID vaccines from Pfizer, Moderna, and Johnson & Johnson currently available in the United States.;
A 90 percent decrease in risk of infections, and 94 percent effectiveness against hospitalization for the Pfizer and Moderna vaccines is fantastic, he said.;
But what makes vaccine experts such as Goepfert confident that COVID vaccines are safe in the long term? We have all seen billboards and TV infomercials from law firms seeking people harmed by diet drugs or acid-reflux medicines for class-action lawsuits. What makes Goepfert think that scientists would not discover previously unsuspected problems caused by COVID vaccines in the years ahead?;
Vaccines are eliminated quickly
Unlike many medications, which are taken daily, vaccines are generally one-and-done. Medicines you take every day can cause side effects that reveal themselves over time, including long-term problems as levels of the drug build up in the body over months and years.;
Weighing the odds
What You Need To Know
- COVID-19 vaccines are safe and effective.
- Millions of people in the United States have received COVID-19 vaccines under the most intense safety monitoring in U.S. history.
- CDC recommends you get a COVID-19 vaccine as soon as possible.
- If you are fully vaccinated, you can resume activities that you did prior to the pandemic. Learn more about what you can do when you have been fully vaccinated.
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Rare Reactions That Have Been Reported
As with all vaccines, there’s a chance that there will be a serious side effect. All side effect reports, including the rare reactions below, continue to be monitored closely by:
- Health Canada
- the Public Health Agency of Canada
- provincial and territorial health authorities
- the manufacturers
Health Canada is:
- working closely with the manufacturers to ensure the labelling reflects relevant information
- continuing to monitor these reports and is working with international regulators to review information as it becomes available
What Is The Fast
Scientists hope to tweak coronavirus vaccines to ensure they continue to offer high protection as new variants of the disease emerge.
The UK’s drug regulator says new vaccines can be fast-tracked for approval if needed.
No corners will be cut, with safety paramount.
But lengthy clinical trials with thousands of volunteers will not be needed.
Instead, data from existing studies and ongoing real-world use could be used.
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Dr Fauci Admits Covid
U.S. National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci reportedly admitted in an interview with Meet The Press that the COVID-19 vaccines are not actually safe for people.
The said interview was cited by Washington Gazette;from a Jan. 29, 2021 New York Post;report. The Gazette said Fauci “blatantly stated that the country needed to ‘make sure’ the vaccine truly is safe before” it is given to children by conducting “hundreds to a couple of thousands” of tests on children.
“The reason is traditionally when you have a situation like a new vaccine, you want to make sure, because children as well as pregnant women, are vulnerable, so, before you put it into the children, you’re going to want to make sure you have a degree of efficacy and safety that is established in an adult population, particularly an adult, normal population,” Fauci remarked;in the said interview.
The Gazette pointed out that this indicates uncertainty in the vaccines’ safety yet would still use it to undertake the test on children who would come from the “general public.”
The Gazette raised that Fauci’s recent statements indicate “there’s no way anyone could have said this vaccine was safe because the trials didn’t consist of a normal population.” It cited Pfizer’s test being performed on “healthy individuals” while Moderna is mum on the type of individuals their clinical trial sample had.
Vaccine-related injuries and deaths
What Is A Third Dose Of The Coronavirus Vaccine
A third dose of the mRNA COVID-19 vaccines is identical to the first two doses. It can help protect people with weakened immune systems who did not have a strong enough response to the first two doses of one of the mRNA vaccines. Such people can get a third dose as soon as 28 days after a second dose. The FDA has authorized, and the CDC recommends, that those with certain medical conditions that suppress the immune system get a third dose of the same brand of COVID-19 vaccine that they initially received.
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Can Any Of The Vaccines Give Me Covid
None of these vaccines contain the virus, so they cant give you COVID-19. These vaccines contain genetic instructions that allow your own cells to make one of the virus proteins. Your immune system reacts to this protein to make antibodies and other immune cells that can recognize and fight COVID-19 if you do get exposed.
Johnson & Johnson Vaccine And Tts A Possible Rare Side Effect
A small number of people have developed a serious blood clot condition after they received the J&J vaccine. Nearly all reports of this problem have been in adult women younger than age 50. A review of all available data at this time shows that the J&J vaccines known and potential benefits outweigh its known and potential risks.
However, women younger than age 50 should be aware of this rare adverse event and should know that other COVID-19 vaccines are available.
For three weeks after receiving the J&J vaccine, you should watch for possible symptoms of a blood clot with low platelets called thrombosis with thrombocytopenia syndrome, or TTS. Although very rare and treatable when diagnosed in time, TTS is serious.
Get medical help immediately if you have any of these symptoms within 3 weeks of receiving the J&J coronavirus vaccine:
- Severe or persistent headaches or blurred vision
- Shortness of breath
- Easy bruising or tiny blood spots under the skin near the injection site
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Pfizer Says Covid Vaccine Is Safe Effective For Kids 5
Sept. 20, 2021 — With record numbers of COVID-19 cases being reported in kids, Pfizer and its partner BioNTech have announced that their mRNA vaccine for COVID-19 is safe and appears to generate a protective immune response in children as young as 5.
The companies have been testing a lower dose of the vaccine — just 10 milligrams — in children between the ages of 5 and 11. Thats one-third the dose given to adults.
In a clinical trial that included more than 2,200 children, Pfizer says two doses of the vaccines given 3 weeks apart generated a high level of neutralizing antibodies, comparable to the level seen in older children who get a higher dose of the vaccine.
On the advice of its vaccine advisory committee, the FDA asked vaccine makers to include more children in these studies earlier this year.
Rather than testing whether the vaccines are preventing COVID-19 illness in children, as they did in adults, the pharmaceutical companies that make the COVID-19 vaccines are looking at the antibody levels generated by the vaccines instead. The FDA has approved the approach in hopes of speeding vaccines to children, who are now back in school full time in most parts of the U.S.
With that in mind, Evan Anderson, MD, a doctor with Childrens Healthcare of Atlanta who is an investigator for the trial and is therefore kept in the dark about its results said its important to keep in mind that the company didnt share any efficacy data today.;
Why Did The Fda And Cdc Pause Administration Of The Johnson & Johnson Vaccine
On Tuesday, April 13, 2021, the Food and Drug Administration and the Centers for Disease Control and Prevention paused administration of the Johnson & Johnson COVID-19 vaccine out of an abundance of caution.
This pause was a result of six women from the United States who experienced blood clots after receiving this vaccine. While these reports are rare, with more than 6.8 million doses of this vaccine administered in the United States with mild or no side effects, pausing the administration of this vaccine allowed the CDC to communicate with health care providers and re-emphasize the importance of reporting severe events in people who have received this vaccine, as well as provide guidance on how to report such events. The pause also gave experts time to carefully review all available data and conduct a risk-benefit analysis around the continued use of this vaccine.
On Friday, April 23, 2021, the CDC and FDA recommended that use of the Johnson & Johnson COVID-19 vaccine resume in the United States.;
Detecting these rare adverse events tells us that the systems in place to monitor the safety of these vaccines are working. The thrombosis with thrombocytopenia syndrome reports were detected early, and the pause reflected the federal governments commitment to transparency and safety as the CDC and FDA gathered and reviewed additional data. COVID-19 vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.
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Cnbc Health & Science
The companies didn’t disclose many details about the trial, including whether any of the kids in the trial experienced myocarditis, a rare heart condition seen in a small number of adolescents and young adults.
The FDA is expected to issue a decision sometime this week on which groups are eligible to get a third dose, or booster shot, of the Pfizer vaccine. An FDA advisory committee on Friday unanimously recommended Pfizer booster shots to people age 65 and older and other vulnerable Americans.
Additionally, Pfizer expects to release clinical trial data on how well its Covid vaccine works in children as young as 6 months to 5 years old as early as the end of October, he said.
Booster Shots And Third Doses For Covid
Lisa Maragakis, M.D., M.P.H., senior director of infection prevention, and Gabor Kelen, M.D., director of the Johns Hopkins Office of Critical Event Preparedness and Response, explain what you need to know about third vaccine doses and COVID boosters. While both kinds of shots are additional doses of the mRNA COVID-19 vaccines , they have different purposes and are intended for different groups of people.
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How Effective Are The Vaccines Against Variants
Soon after the triumph of Keenans first dose, the world had a fresh reason to worry. A SARS-CoV-2 variant identified in the United Kingdom seemed to be spreading unusually fast; a different variant first identified in South Africa carried worrisome mutations in the coronavirus spike protein that serves as the basis for most COVID-19 vaccines in use.
Since then, further variants of concern have arrived in a steady parade, brandishing mutations that might boost the viruss spread, or undermine the effectiveness of COVID-19 vaccines. Uncontrolled outbreaks generate mutants, says Jerome Kim, director-general of the International Vaccine Institute in Seoul.
Initial laboratory tests suggested that antibodies raised by the PfizerBioNTech vaccine were less effective against the B.1.351 variant identified in South Africa, but it was unclear how that would affect protection against disease. In May, researchers in Qatar published reassuring data showing that people who received two doses of the PfizerBioNTech vaccine were 75% less likely to develop COVID-19 from infection with B.1.351, and were almost completely protected from severe disease. The big question right now is whether introduction of other variants could change the situation, says study author and infectious-disease epidemiologist Laith Jamal Abu-Raddad at Weill Cornell MedicineQatar in Doha. We are watching this on a daily basis, but we have optimism that maybe we have seen the worst.
Who Approves Vaccines Or Treatments
Approval is only given in the UK if the regulator is happy that a vaccine is safe and effective.
Checks continue after approval to make sure there are no further side effects or long-term risks.
Independent experts on the Joint Committee on Vaccination and Immunisation decide how best to use a vaccine and who should get it.
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Immunity To The Coronavirus Remains A Mystery Scientists Are Trying To Crack The Case
Still, the immune correlate studies could more broadly inform the discussion about when and whether people or at least certain groups of people should get a booster shot. The research groups are continuing to follow the study volunteers and will track their antibody levels. If they drop over time, and in turn theres an increase in Covid-19 cases among those people, it could point to the level at which people should receive another shot.
We can track these individuals and look at if their antibody titers start to go down, but we dont know how far they have to go down at this point to say, Well your risk of infection is significant enough that we would recommend a third vaccine, Houchens said.
Thrombosis With Thrombocytopenia Syndrome After Vaccination With J&j/janssen Covid
After receiving the J&J/Janssen COVID-19 Vaccine, there is risk for a rare but serious adverse eventblood clots with low platelets . Women younger than 50 years old should especially be aware of their increased risk for this rare adverse event. There are other COVID-19 vaccines available for which this risk has not been seen.
This adverse event is rare, occurring at a rate of about 7 per 1 million vaccinated women between 18 and 49 years old. For women 50 years and older and men of all ages, this adverse event is even more rare.
Cases of myocarditis and pericarditis in adolescents and young adults have been reported more often after getting the second dose than after the first dose of one of the two mRNA COVID-19 vaccines, Pfizer-BioNTech or Moderna.;These reports are rare and the known and potential benefits of COVID-19 vaccination outweigh the known and potential risks, including the;possible risk of myocarditis or pericarditis.
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Will The Vaccine Give Me Side Effects
Vaccines do not give you a disease. Instead, they teach your body’s immune system to recognise and fight the infection they have been designed to protect against.
Some people do experience mild to moderate symptoms after being vaccinated. This is not the disease itself, but the body’s response to the vaccine.
Common reactions that may affect more than one in 10 people and typically get better within days include chills, tiredness and aching muscles.