Pfizer has submitted data to the U.S. Food and Drug Administration to approve its Covid booster vaccination for all Americans aged 18 and over.
The company made a joint statement with BioNTech, the Germany-based company it works with to develop and market the vaccine, and announced the filing on Tuesday.
If approved, the Pfizer booster will be the first to be approved for all American adults.
Currently, anyone who got their second dose of vaccine six months ago – or two months ago for those who received the one-time Johnson & Johnson vaccine – and is over 65 years of age has had severe comorbidities or a job that puts it at risk Covid exposure triggers is eligible for the Pfizer Booster Shot.
Pfizer has submitted data to the FDA in hopes of getting its Covid booster approved for all American adults. Pictured: A Pfizer COVID-19 vaccine vial, November 2021
The Phase 3 clinical trial data submitted to the FDA found that the Covid booster reduced the likelihood of infection by 96%. Pictured: A man in Lille, France, receives an injection of a COVID-19 vaccine
“In October, the companies announced positive topline results from the study, showing that a booster dose given to people who had previously received Pfizer-BioNTech’s primary two-dose range showed a relative vaccine effectiveness of 95 percent compared to those who which is not a booster, “reads a statement released by the company.
“To date, these are the first and only efficacy data published from a randomized, controlled COVID-19 vaccine booster study.”
The statement states that there were no new changes to the side effect profile of the vaccination in clinical studies with the booster.
It should also be noted that the booster has been approved by the European Union regulators for all residents over the age of 18.
The Phase 3 clinical trial data presented to regulatory authorities is based on a study conducted in the United States, Brazil, and South Africa.
The study included more than 10,000 people aged 16 years or older, each previously fully vaccinated with Pfizer’s vaccine called Comirnaty.
Half of the participants received a 30 microgram dose of the booster and the others received a placebo.
After a follow-up exam with each participant about two months later, the researchers found that the booster reduced the risk of infection for people of all ages by 96 percent.
The Pfizer booster is the most popular among Americans to date, with more than half of the 25 million Americans who have received booster shots to date choosing the jab.
More than 98 percent of Pfizer recipients for their first two shots chose, along with 32 percent of J&J recipients, to get the same shot again for their booster.
Pfizer is likely to get approval for the booster vaccination earlier this week, according to a report in the Washington Post.
Booster vaccinations for immunocompromised people were made available for the first time in August.
Shortly thereafter, the White House put forward plans to make the additional footage available to all U.S. adults in late September.
However, the booster jabs could not overcome the regulatory hurdles beforehand, resulting in a delay of over a month in the introduction of the boosters to all Americans.
The reason the White House is so eager to have booster shots spread across America is because the stitches are becoming less effective.
Recently released data from the Public Health Institute shows that the overall effectiveness of COVID-19 vaccines fell below 50 percent in September, the first month this happened.
The combined effectiveness of the COVID-19 vaccines fell below 50% in September. The J&J vaccine is the least effective and only reduces the risk of infection by 13%. Pfizer’s shot reduces the risk of infection by 43% and the Moderna by 58%
The effectiveness of the Pfizer vaccine had dropped 43 percent by September, the research found.
J & J’s vaccine protection fell the most, dropping from 86 percent in March to below 50 percent by September and to just 13 percent last month.
Moderna’s shot held up best and is the only one of the three that is still more than 50 percent effective.
The effectiveness of the shot, however, has still dropped sharply, from 89 percent in March to 58 percent in September.
Experts hope that the wider appropriateness of booster vaccinations will help increase the overall effectiveness of vaccines and contain future Covid outbreaks.