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Pfizer seeks FDA approval for COVID-19 booster shot for ALL Americans 18 and older

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Pfizer has filed data with the U.S. Food and Drug Administration (FDA) seeking approval for its Covid booster injection for all Americans 18 and older.

The company gave a joint statement on Tuesday with its German partner BioNTech announcing the submission.

If authorization is given, the Pfizer booster will be the second authorization for all US adults.

Currently, anyone who received their second vaccine dose six months ago — or two months ago for those who received the one-time Johnson & Johnson vaccine — and over 65 have an underlying condition or job that puts them at risk for exposure to Covid qualifies for the Pfizer booster shot.

Pfizer has filed data with the FDA in hopes of getting the Covid booster shot authorized for use in all U.S. adults. Pictured: A bottle of Pfizer COVID-19 vaccine, November 2021

Data from the Phase 3 clinical trial submitted to the FDA showed that the Covid booster injections reduced the chance of infection by 96%.  Pictured: A man in Lille, France, receives an injection of a COVID-19 vaccine

Data from the Phase 3 clinical trial submitted to the FDA showed that the Covid booster injections reduced the chance of infection by 96%. Pictured: A man in Lille, France, receives an injection of a COVID-19 vaccine

In October, the companies announced positive top-line results from the study showing that a booster dose given to individuals who previously received the primary series of two doses of Pfizer-BioNTech showed 95 percent relative vaccine efficacy compared to those who have no booster’, pronunciation released by the companies.

“To date, these are the first and only efficacy data disclosed from a randomized, controlled COVID-19 vaccine booster study.”

The statement notes that there were no changes in the number of side effects that occurred after the booster compared to the original vaccine.

It also notes that the booster has received approval from European Union regulators for all residents over the age of 18.

The Phase 3 clinical trial data submitted to regulators comes from a study conducted in the US, Brazil and South Africa.

More than 10,000 people aged 16 or over were enrolled in the trial, and each had previously been fully vaccinated with the injection of Pfizer – marketed as Comirnaty.

Half of the participants received a 30 microgram dose of the booster and the others received a placebo.

After tracking with each participant about two months later, researchers found that the booster reduced the risk of infection in people of all age groups 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 opt for the jab.

More than 98 percent of Pfizer recipients for their first two injections decided to receive the same injection again for their booster, along with 32 percent of J&J recipients.

According to a report from the Washington Post earlier this week, Pfizer is likely to get approval for the booster shots.

Booster shots were first made available to immunocompromised in August.

Shortly after, the White House made plans for the additional recordings to be available to all American adults by the end of September.

At the time, Pfizer said the early data suggested that people given booster doses had a high level of protection between six and 12 months after their last dose.

The company filed for emergency booster dose approval in late August and filed data with the FDA, which was made public last week.

The documents suggest that protection against two doses of the Pfizer vaccine drops from 96.2 percent seven days after dose 2 to 90.1 percent two months later to 83.7 percent up to six months later.

In addition, they cited data from Israel showing that people who were fully vaccinated in January 2021 had a 2.26-fold increased risk of breakthrough infections compared to those who were fully vaccinated in April 2021.

Another Israeli study discussed in the documents showed efficacy against infection was 39 percent and against symptomatic diseases 40 percent from June 20, 2021 to July 17, 2021, when the Delta variant was the dominant strain.

By comparison, between January and April, these rates were 95 percent or higher.

The team also released data from a clinical trial of 23 participants who participated in Pfizer’s early-phase trials last year.

They had each received two doses of the vaccine and were given a booster dose at least six months later.

Of the participants, 11 were in the The group of younger adults ages 18 to 55 and 12 were 65 to 85 years old.

However, the booster jabs failed to clear the regulatory hurdles, leading to a more than a month delay in the rollout of the boosters to all Americans.

The reason the White House is so eager to get booster shots rolling across America is the dwindling efficacy of the jabs.

Recently published data from the Public Health Institute shows that the overall effectiveness of COVID-19 vaccines fell below 50 percent in September, the first month in which that happened.

The combined effectiveness of the COVID-19 vaccines has fallen below 50% since September. The J&J vaccine is the least effective and reduces the risk of infection by only 13%. Pfizer’s shot reduces the risk of infection by 43% and the Moderna by 58%

The effectiveness of the Pfizer vaccine had decreased by 43 percent by September, the study found.

J&J’s vaccine saw its protection decline the most, from 86 percent in March to below 50 percent in September, and to just 13 percent last month.

Moderna’s shot held up the best and is the only one of the three that is still more than 50 percent effective.

However, the effectiveness of the injection has still fallen sharply, from 89 percent in March to 58 percent in September.

Experts hope the wider appropriateness of booster shots will help increase the vaccines’ overall effectiveness and help curb future Covid outbreaks.

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