Drugmaker, Johnson & Johnson is planning to ask the U.S. regulator, Food and Drug Administration (FDA) to authorize a booster shot of its COVID-19 vaccine, according to officials familiar with the company’s plans.
This comes after drugmakers Pfizer and BioNTech commenced submission of data to the FDA for the authorisation of their COVID-19 vaccine for children of ages five to 11.
Last week, the FDA scheduled a meeting for October 15, 2021, for its expert advisory committee to determine whether to grant emergency use authorization for a booster shot of J&J’s vaccine.
Why this matters
Recall that, the Biden administration in August announced the push for an extra dose as part of an effort to ensure protection against the latest Covid-19 variant, Delta variant. However, scientists are unable to agree over the need for booster shots in the United States, as scientists against the move cite reasons around the inaccessibility of the vaccines in other countries which leaves a larger part of their countries unvaccinated.
In the United States of America, according to the CDC, over 15 million Americans have been documented to receive the J&J’s vaccine, which is administered as a single dose.
Last month, Johnson & Johnson announced that an additional second shot of its vaccine given two months after the first shot increases its potency to 94%, compared with 70% effectiveness with the single shot.
Unlike J&J, the FDA has already authorized a booster dose of the Pfizer Inc and BioNTech vaccine for those 65 and older, including people who are highly at risk of severe diseases and people who are front-line workers or frequently exposed to the virus.
In addition, rival Moderna Inc also submitted its application seeking the FDA’s authorization for a booster shot of its two-dose vaccine last month and the regulator’s Advisory Committee panel is scheduled to hold a meeting on the 14th of October to discuss the feasibility of an additional dose.