FDA approves Pfizer-BioNTech COVID19 booster for older and high-risk Americans, Know details

FDA authorized a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for those aged 65 and older and adults at high risk. Know what is a COVID booster shot?

Created On: Sep 23, 2021 16:29 IST
Pfizer COMIRNATY booster vaccine, Source: Reuters
Pfizer COMIRNATY booster vaccine, Source: Reuters

COVID19 booster shots: The US Food and Drug Administration (FDA) on September 18, 2021, authorized a single booster dose of the Pfizer-BioNTech COVID-19 vaccine Comirnaty for those aged 65 and older and adults at high risk of severe diseases or high-exposure jobs. The booster dose is to be administered at least 6 months after completing the second dose of initial vaccines. The authorization came in after an advisory panel of the US Centers for Disease Control and Prevention (CDC) voted on September 23, 2021, on the use of a third shot of the vaccine.

US is likely to start distribution of Pfizer COVID19 booster shots during the week of September 20. The FDA authorization will be followed as soon as the CDC gives its recommendation on September 23.

What is a COVID19 booster shot?

A COVID19 booster dose refers to another dose of a vaccine that is administered to people who have received their original shots of the vaccines but their immunity from the original shots of earlier vaccines has begun to decrease over time. Decreasing immunity is called waning immunity.

Pfizer-BioNTech COVID19 Booster Vaccine: Key Points

Who will get COVID19 booster shots?

The FDA panel has authorized COVID-19 booster shots of the Pfizer-BioNTech vaccine for:

(i) Individuals aged 65 or older,

(ii) Individuals at high risk of severe COVID-19 or at risk of getting severely ill due to complications from the COVID-19 infection,

(iii) Individuals who are working jobs that put them in frequent exposure to COVID-19

How many people are expected to get COVID19 booster shots?

As per the Centers for Disease Control and Prevention (CDC), approximately 22 million Americans are at least 6 months past their second dose of the Pfizer-BioNTech vaccine. Of these 22 million, half are 65 or older.

Study and Data to allow COVID19 Booster Vaccine

FDA received a request from Pfizer for approval of a single booster dose of its Comirnaty COVID19 vaccine to be administered in individuals aged 16 and older. Comirnaty is an mRNA COVID19 vaccine that was approved by the FDA on August 23, 2021.

The FDA based on the available data for COVID-19 vaccines, the totality of the available scientific evidence and deliberations of the advisory panel amended the Emergency Use Authorization for the Pfizer-BioNTech COVID19 vaccine to allow a booster shot among certain populations that includes health care workers, daycare staff, teachers, homeless shelters, prisons, grocery staff, etc.

FDA analyzed the immune and safety response data from a group of participants from the clinical trial of the Pfizer-BioNTech COVID19 vaccine. The group of participants included 306 participants divided into age groups of 18 to 55 years and 65 years and older.

Side Effects of COVID19 booster shots: Clinical trial

The most common side effects reported among those administered with the Pfizer-BioNTech COVID19 booster shots were redness, pain, swelling at the point of the injection site, headache, fatigue, chills, muscle or joint pain, and swollen lymph nodes in the underarm.

Also read: FDA approves first COVID-19 vaccine – All you need to know

FDA rejects booster shots for aged 16 and older

US President Joe Biden had announced the plan of the government to introduce booster shots for people aged 16 and older this week. The FDA advisors recommended COVID-19 vaccine booster shots for Americans aged 65 and older as well those at high risk of diseases or severe illnesses.

However, the panel rejected the call for broader approval of the vaccine for people aged 16 or older stating that there was not enough evidence to support booster shots for all those aged 16 and older who had been administered a second dose at least 6 months ago.

The panel could take up the case of booster shots for a broader population including those aged 16 and older. They have requested more safety data on the same.

Other countries allowing COVID19 booster shots

As per CDC data, countries including Austria, Belgium, Britain, Czech Republic, Germany, Hungary, Luxembourg, Lithuania, Sweden, Slovenia, Israel, and Serbia have allowed booster shots.

The US had authorized COVID19 booster shots in August 2021 only for people with a compromised immune system. Over 2 million people in the US have received their booster or third shot.

Also read: What is Vaccine Passport and How you can get one?

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