FDA authorizes Pfizer COVID-19 Booster Doses

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FDA (Food and Drug Administration) of the United States granted its permission to emergency use for the third dose of Pfizer-BioNTech COVID-19 vaccine as a single booster dose. FDA authorizes vaccines for three groups. FDA emphasizes that individuals who are 65 years of age and older must take the vaccine before anyone else. After that, individuals between 18 and 65 at high risk of severe COVID-19 will receive the booster dose comprehensively. The last bunch will be people whose frequent institutional or occupational exposure to SARS-CoV-2 from the second group, including frontline health care workers.

FDA strongly noted that this authorization puts into the Pfizer-BioNTech COVID-19 Vaccine. FDA is still figuring out other vaccines for the booster dose. However, sooner rather than later, FDA will allow other vaccines such as Moderna and J&J.

Acting FDA Commissioner Janet Woodcock M.D. has expressed his thoughts about the situation. This global pandemic is evolving all the time, even at this moment. New data & reports, updates are becoming available every day. Then we can improve the effectiveness of vaccines by applying them. And it helps to learn more about the safety of COVID-19 vaccines. After that, we can give more accurate and confirmed information about the vaccines to the public. Afterward, people will follow the guidelines and get vaccinated as quickly as they can.

The approval is not come by a sudden decision. It came from a successful procedure. FDA’s advisory committee worked hard for it day and night. They made use of available scientific evidence throughout the whole operation. Independent, external experts and specialists were on the committee. After all of that, FDA amended the EUA (Emergency Use Authorization) for the Pfizer vaccine for a single booster dose.

FDA has already granted its full approval for the first two doses of the Comirnaty vaccine to use in everyone above sixteen. Now, third shots for select portions of the American population will allow commencing. However, many vaccine providers will have to wait until a formal recommendation for the third dose arrives. It will recommend by the Centers for Disease Control and Prevention under federal agreements governing the use of the shots.

The CDC Advisory Committee on Immunization Practices met to discuss several important things. They extensively talked about the potential use of Pfizer booster doses. The committee utilized the data from the people who have received extra vaccine shots. However, they will vote their guidelines for additional vaccine shots. It will be a full guideline report. Previously, they had a plan to prioritize the booster doses to doctors, nurses, and those at high risk. They expected to reduce the deaths rate from it.

Pfizer and BioNTech (German partner) originally had sought full approval for booster doses from the FDA and respective officials. They had looked in all individuals at 16 years old and older at once. The Pfizer-BioNTech authority had presented several reports about the effectiveness of their vaccine. It included own impartial trials and data from other countries that have given third doses.

The CDC presented a report containing new data about the Delta variant. It included that vaccine effectiveness might drop by a massive scale against the Delta variant. And older adults are at risk more than younger ones against the upcoming new variants of COVID-19. Scientists of the CDC had some theories. According to those, they also presented several suggestions and models which they created against the trend. It suggested booster doses of vaccination programs could help curb cases in nursing homes.

More than 2.2 million Americans have received additional shots since authorities first allowed another dose after fully vaccinating for some immunocompromised people. Yet, no one has reported safety concerns about the third dose of the Pfizer vaccine, CDC officials said. The hospitalization rate has decreased significantly among those who received two jabs in order. And complications of COVID-19 also has reduced alongside the death rate. These statistics affected them in a stark contrast way for the unvaccinated Americans. It suggested that vaccination is the best option to survive from COVID-19.

Lately, CDC has investigated the Delta variant outbreak in different ways and methods. They had released the investigation report about the sudden Delta variant outbreak at a federal prison in Texas. Surprisingly, more than 70% of fully vaccinated inmates tested positive for COVID-19. It clearly showed that how dangerous a breakthrough can be in a crowded area.

FDA has a selected panel of vaccine advisers. They expressed their deep concerns about the gaps in the data. It is hard to make decisions without accurate data. Every single decision about the outbreak and the vaccine program comes from data. However, they barely agreed to grant their permission for the booster doses after the emergency meeting.

Dr. Peter Marks is the top official of the FDA’s vaccine committee. He thanked doctors, scientists, leading vaccine experts, and other members of the advisory committee. Overall the advisory committee did a great job by ensuring transparent discussions about the vaccination program. Dr. Peter said via a statement.

FDA’s decision to authorize Pfizer booster shots came from the input of the committee. Then FDA thoroughly reviewed and confirmed it. The booster doses of Pfizer will only allow to people who received both doses. And there is one more consideration too. After at least six months from their second dose will be eligible for booster doses. But the time gap might change ahead.

The federal health officials expect most Americans will need an additional dose. Perhaps, it will have to continue for quite some time once a year or like that. On the other hand, FDA officials are wrapping up the pre-check to authorize Moderna and Johnson & Johnson booster doses.

Recently, Moderna officials submitted relevant data to get approval for a booster dose of its COVID-19 vaccine. And Moderna decided to halve its booster dose from 100 micrograms to 50 micrograms. Pfizer also used the same for the booster dose. Johnson & Johnson has checked its trials for the third dose as well. National Institutes of Health is working on for release data from mix-and-match booster shots trials. The scientists will announce the result sooner.