USFDA approves Pfizer booster shots for certain population, issues guidelines

The third dose of Pfizer’s Covid-19 vaccine is now available to adults over the age of 65 and those at high risk of severe coronavirus infection in the United States. Furthermore, persons 18 and older who have been exposed to Covid-19 at work and are at an increased risk of severe consequences are eligible to get the Pfizer booster dosage. Pfizer’s booster dosage, according to the US Food and Drug Administration (FDA), can be delivered at least six months after a person has had both doses.

Pfizer Chief Executive Officer Albert Bourla said that FDA’s decision to allow the emergency use authorization for a booster dose is “an important step in helping the most vulnerable among us remain protected from Covid-19”.

1. Eligibility for Pfizer’s third booster dose

According to the US FDA guidelines, the following categories of people can take Pfizer’s booster shot:

individuals 65 years of age and older;
individuals 18 through 64 years of age at high risk of severe COVID-19
individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of coronavirus.

2. Pfizer booster shot side-effects

The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain, redness, and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills. Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.

3.Antibody analyses of Pfizer booster shot

The immune responses of approximately 200 participants 18 through 55 years of age who received a single booster dose approximately six months after their second dose were assessed. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.

4.Scientists’ views on the third dose

Scientists have been divided on this matter. An expert view of scientific evidence has concluded that Covid-19 vaccine booster shots are not needed for the general public. They say that unnecessary boosting can cause unnecessary adverse reactions, such as myocarditis–rare heart inflammation. However, scientists have acknowledged that booster shots might eventually be needed for the general population if vaccine-induced immunity wanes even further or a new variant emerges that can evade the protection of the shots.

5. What doses Centers for Disease Control and Prevention (CDC) says on booster shot

Pfizer Covid-19 boosters are currently being debated by a separate body of experts convened by the as well. According to a bunch of CDC experts, if obesity is considered as putting a person “at high risk of severe Covid,” then it would cover over 40% of the US population aged over 20.

6. Is the booster shot only for the Pfizer vaccine?

Currently, the US FDA has approved the Pfizer vaccine’s booster dose. It could be because recent studies have found that Moderna was 95% at preventing hospitalizations among adults ages 18 and older.  Whereas, Pfizer was only 60% effective at preventing hospitalizations among adults of similar age groups. And, Jhonson & Johnson was 60% effective.

But, FDA vaccine official Doran Fink told the panel that the agency is “working as rapidly as possible” to review Moderna’s booster submission.

Some experts have questioned whether people who have received two doses of Moderna or a single dose of J&J vaccine should receive the Pfizer booster, or whether they should wait to match with a supplemental dose of the shot they first received.

7. WHO’s opinion of Pfizer booster shot

The World Health Organization Director-General Tedros Adhanom Ghebreyesus said that booster shots should wait until immunisations are more widespread globally. The WHo chief has argued that uneven vaccine distribution will be the world’s biggest obstacle to ending the pandemic and recovering

8. Countries that have allowed giving booster shots

Austria, US, Belgium, Czech Republic, Germany, Hungary, Lithuania, Luxembourg, Slovenia, Sweden, Israel, and Serbia

9. Pfizer vaccine for children

This week, Pfizer Inc said that its vaccine has induced a robust immune response in 5 to 11-year-olds, and they plan to ask for regulatory authorisation to use the shot in children in the US. The Pfizer/BioNTech vaccine already has won U.S. regulatory authorization for people age 12 and up.

10. Joe Biden doubles US global donation of Pfizer vaccine

President Joe Biden has announced that the US is doubling its purchase of Pfizer’s shots to share with the world to 1 billion doses as he embraces the goal of vaccinating 70% of the global population within the next year.

Medically Speaking Team

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