EU approves Pfizer-BioNTech COVID-19 booster dose, know details

COVID19 booster shots: The EMA approved the single booster dose of the Pfizer-BioNTech COVID-19 vaccine Comirnaty. Know key details.

Created On: Oct 5, 2021 16:24 IST
Pfizer-BioNTech COVID-19 booster dose, Source: Reuters
Pfizer-BioNTech COVID-19 booster dose, Source: Reuters

COVID19 booster shots: The European Medicines Agency (EMA) on October 4, 2021, approved the single booster dose of the Pfizer-BioNTech COVID-19 vaccine Comirnaty for those aged 18 and older. The public health bodies will issue directions at the national level to the EU member states on the use of booster vaccines in accordance with the EMA. In a statement, the EMA on October 4 stated that the decision on COVID19 booster shot was taken after studying the efficacy and safety of booster doses.

Several European member states are already running their COVID booster campaigns including Italy, Germany, France, and Ireland. Though the rules of eligibility for COVID booster doses in each country are different. The US Food and Drug Administration (FDA) authorized a single booster dose of the Pfizer-BioNTech COVID-19 vaccine on September 18, 2021.

EU drug panel approves Pfizer’s COVID-19 booster dose

The European Medicines Agency (EMA) approved the single booster dose of the Pfizer-BioNTech COVID-19 vaccine Comirnaty for those aged 18 and older after evaluating the data of the vaccine that showed an increase in the levels of antibodies in people aged 18 to 55 years old after being administered with a booster dose, about six months after receiving their second dose of vaccine.

Studies also showed that a booster dose of Pfizer-BioNTech and Moderna COVID vaccines increased the ability to produce antibodies to fight against COVID-19 infection in organ transplant patients with severely weakened immune systems.

The EMA further noted that the side effects and risk of inflammatory heart conditions after being administered with a COVID-19 booster dose are not yet known and are being evaluated.

EMA recommendations on use of Pfizer’s COVID19 booster dose

The European Medicines Agency (EMA) has advised to:

(i) Administer booster doses at least 6 months after the second dose for people aged 18 years and above.

(ii) Administer a booster dose of Pfizer-BioNTech and Moderna vaccines to people with severely weakened immune systems at least after 28 days of their second dose of vaccine.

FDA approved Pfizer-BioNTech COVID19 booster dose

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.

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

What is COVID19 booster dose?

A COVID-19 booster dose is another or usually third dose of a COVID vaccine that is given to people who have already been administered with their original doses of a vaccine but over time their immunity level from earlier doses is starting to wear off.

Comirnaty, a Pfizer-BioNTech mRNA vaccine is a single-dose booster shot of the Pfizer-BioNTech COVID vaccine that induces higher neutralizing antibodies against the SARS-CoV-2 virus infection as well as the Beta and Delta variants of COVID-19.

 

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