Johnson & Johnson requested the Food and Drug Administration on Tuesday to authorize more doses of its COVID-19 vaccine as the US government wants to expand its booster campaign to reach millions more immunized Americans.
J&J said it has submitted a request to the FDA for boosts for anyone aged 18 and above who had received prior the company’s one-shot vaccination. While the firm stated that it submitted data on a variety of booster intervals ranging from two to six months, it did not explicitly propose any to authorities.
J&J Urges FDA To Authorize More Covid Doses
Last month, the FDA authorized booster doses of Pfizer’s COVID-19 vaccine for elderly Americans and other groups at high risk. It is part of a wider effort by the Biden administration to strengthen up protection in the face of the delta variant and perhaps waning vaccine immunity.
Government experts supported the extra Pfizer injections but were concerned about confusing the tens of millions of other Americans who had gotten the Moderna and J&J doses. Officials in the United States do not suggest combining various vaccination brands.
The FDA’s independent team of advisors will meet next week to evaluate booster data from both J&J and Moderna. It is the first stage in a review procedure that also includes approval from the FDA and the Centers for Disease Control and Prevention.
J&J recently disclosed data indicating that their vaccine is still extremely effective against COVID-19 at least five months after immunization, with 81 percent efficacy against hospitalizations in the United States.
However, corporate research suggests that a booster dosage at either two- or six months boosts immunity even more. A two-month booster offered 94 percent safety against severe COVID-19 infection. Clinical data on a six-month booster injection has yet to be disclosed by the firm.
Next Friday, the FDA’s advisors will evaluate data from the business and other experts and vote on whether to suggest boosters.
Considering that the FDA already had planned a meeting on the company’s evidence, the timing of J&J’s file was unexpected. Corporations often submit their requests well ahead of meeting announcements. According to a J&J official, the firm has been cooperating with the FDA on the review.
Because it’s COVID, both J&J and the FDA have a feeling of urgency, and they want excellent data out there turned into action as quickly as feasible.
Because it only takes one injection, the vaccine from the New Brunswick, New Jersey-based firm was seen as a significant instrument in the fight against the epidemic. However, its introduction was hampered by a slew of issues, including production issues at a Baltimore plant that required J&J to import millions of doses from overseas.
Additionally, authorities have added warnings about the shot’s uncommon adverse effects, such as a blood clot disease and a neurological response known as Tubulin syndrome.
In both situations, officials determined that the advantages of the injection outweighed the unusual dangers.
Pfizer and Moderna, two rival pharmaceutical companies, have supplied the great majority of COVID-19 vaccinations in the United States. More than 170 million Americans have been completely immunized with the businesses’ two-dose injections, but just around 15 million have received the J&J vaccine.