US FDA Approves COVID-19 Booster Shots for All Adults: What to Know


The US Food and Drugs Administration, on Friday, 19 November, has authorised a third booster dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines for all adults.

Amending the EUA (Emergency Use Authorisation) granted to both the COVID-19 vaccines, the FDA announced that everyone who has received two doses of either of the vaccines will be eligible to receive a third booster dose.

Everyone over the age of 18 who received the Johnson and Johnson single shot vaccine were allowed a second booster shot earlier on.

All adults who have received two doses will be able to take a third booster dose atleast 6 months after the second dose. In the case of the single shot vaccine, Janssen, they can take the booster dose after two months of being vaccinated.

The US CDC is yet to discuss and issue their own guidelines regarding boosters.


COVID Booster Shots in the US

The US had in September, after much heated debate between various health authorities, decided to limit booster doses of COVID vaccines only to elderly (over 65 years) and immunocompromised people who may be at a higher risk of severe COVID symptoms and even death.

The move to introduce boosters was a way of countering the rise in COVID cases as a result of waning vaccine efficacy and a spike in breakthrough infections.

Moreover, the move to make all vaccinated adults eligible for booster doses, the US FDA says, is also to uncomplicated the whole process.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one.”
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research in the statement

What of the side effects?

Speaking of their decision, and addressing the issue of vaccine side effects, the US FDA, in a statement, said that after both Moderna and Pfizer BioNTech had submitted their data for consideration of their respective booster doses, the FDA has also received sufficient real-world data on the basis of which they re-accessed their stance on allowing a third booster dose.

"The FDA has determined that the benefits of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccines outweigh the risks of myocarditis and pericarditis in individuals age 18 years of age and older when used following completion of primary vaccination," reads the statement.

COVID-19 Booster Doses in India

In India, no COVID vaccine booster shot has been authorised so far. However, this may be set to change soon.

The Indian Medical Association, earlier this week, had recommended giving a third booster dose to health care workers in light of vaccines waning, and the number of daily COVID cases once again seeing an upward trend.

Expert opinion on whether India needs booster doses yet, especially the general population, is divided. Although, most agree that given the limited supply and means of distribution of COVID-19 vaccines in the country, India should first focus on fully vaccinating most of its population before moving on to giving boosters.

Speaking to FIT about this for a previous article back in August, Immunologist Dr Satyajit Rath, "As matters stand, much of the world, and much of India, for that matter, has not received even a first dose of any Covid vaccine, making all this conversation about booster doses extremely self-serving."

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