Sunday, January 29, 2023

Pfizer Asks FDA To Approve COVID-19 Vaccination For All Adults

On Tuesday, Pfizer asked US regulators to allow COVID-19 vaccine boosters for anyone over 18, amid concerns about the increase in the spread of the coronavirus during holiday travel and gatherings.

Older Americans and other groups particularly vulnerable to the virus have gained access to a third dose of Pfizer and BioNTech vaccine since September. But the FDA said it will rapidly distribute boosters for younger ages if warranted.

Pfizer presents the first results of a booster study involving 10,000 people to prove it is time to further expand the booster campaign.

While all three vaccines used in the United States continue to provide reliable protection against serious illness and death from COVID-19, the effectiveness of vaccines against milder infections may decline over time.

A new study by Pfizer concluded that the booster can restore protection against symptomatic infection by up to about 95%, even when the extra-contagious delta variant builds up. The side effects were similar to those seen with the first two shots of the company.

On average, 11 months after the last Pfizer vaccination, trial participants received a third dose or dummy vaccine. Researchers tracked any infections that occurred at least a week later and so far counted five cases of symptomatic COVID-19 among booster recipients, compared to 109 cases among people who received bogus vaccinations.

More on the COVID-19 pandemic

The Biden administration initially envisioned boosters for all adults, but faced major setback in September when FDA scientific advisers rejected additional doses of Pfizer for everyone. The group was not convinced that young healthy people needed another dose, especially when most of the world’s population remains unvaccinated, and instead recommended booster vaccinations for certain populations only – one in a series of additional dose decisions for all three vaccines used in the United States.

Rules in force: People who initially received the Pfizer or Moderna vaccine are eligible for booster vaccinations after six months if they are 65 or older, or are at high risk for COVID-19 due to health, work, or living conditions. Because Johnson & Johnson’s single-dose vaccine has not proven to be as effective as its two-dose competitors, any J&J recipient can receive a booster shot in at least two months.

In addition, anyone eligible for the booster does not have to stick to their original vaccination type and can get another company’s vaccine, which is called mixing and matching.

About 194 million Americans are fully vaccinated. In line with today’s policy, the authorities have already calculated that roughly 2 out of every 3 vaccinated adults may be eligible for booster vaccinations over the next few months. Many of those who do not meet the criteria often receive additional vaccinations because many vaccine providers do not qualify.

FDA spokeswoman Alison Hunt said the agency would review Pfizer’s application “as soon as possible,” but would not set a timeline for a decision. She also said the FDA has yet to decide whether to convene an external expert panel to review the data.

If the FDA approves Pfizer’s request for enhanced boosters, the Centers for Disease Control and Prevention will make recommendations for their use.

Globally, boosters are also a hodgepodge. In some countries, they are limited to the elderly or those in poor health, while in others there are several restrictions. In Israel, for example, Pfizer boosters are allowed for everyone 12 and older. The Canadian regulator on Tuesday authorized Pfizer boosters for people 18 and older.


AP Health article author Matthew Perrone contributed to this report.


The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

Nation World News Desk
Nation World News Desk
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