Johnson & Johnson Submitted Booster Dose Data to FDA for Approval

On Tuesday, Johnson & Johnson said that it has asked the United States Food and Drug Administration to approve third doses or booster shots for its COVID-19 vaccine.

Johnson & Johnson Submitted Booster Dose Data to FDA for Approval

On Tuesday, Johnson & Johnson said that it has asked the United States Food and Drug Administration to approve third doses or booster shots for its COVID-19 vaccine, but has left it up to the US Centers for Disease Control and Prevention Centers and FDA to decide just who should receive their extra shots and when.

The Global Head of R&D for J&J’s vaccine arm, Dr. Mathai Mammen, told CNN that they’re describing the data to them. Moreover, J&J intends to submit its extra dose data to other drug regulators worldwide, along with the WHO and National Immunization Technical Advisory Groups.

In September, Pfizer Inc. received the US FDA’s “OK” for its vaccine boosters for certain people who received the initial two shots at least 6-months before. That’s the part of an all-out effort by the US leader’s to bolster protection amid the highly infectious Delta variant and potential declining jab immunity.

Biden’s administration advisors supported the additional Pfizer doses, but they were also concerned regarding creating confusion for millions of US nationals who got the J&J and Moderna doses. American officials do not suggest a mix-and-match of different vaccines.

How Many Americans Vaccinated with Pfizer, Moderna, and J&J Vaccines?

Mammen said they proclaimed that the 6-month data are very strong, like an amazingly strong boost. And that sixty-day is a good boost, and the two-month fine boost was linked with 94 percent jab efficacy, for all ages.

Booster doses of J&J’s vaccine could commence rolling within the coming few weeks, as the drug firm declared Tuesday it has submitted data to the FDA before it meets upcoming week to determine if to approve a second dose for those eighteen years and up.

The pharmaceutical company released trial data in recent two months proposing an extra dose of the one-dose jab is effective, with the firm finding a 2nd shot given 56 days after the initial generate 94 percent protection and complete protection against serious illness as of two weeks post-booster dose.

Johnson & Johnson Submitted Booster Dose Data to FDA for Approval
Johnson & Johnson Submitted Booster Dose Data to FDA for Approval
Source: Web

According to the US CDC, around 15M doses of Johnson & Johnson coronavirus vaccine that have been administered in America, with 14.85M US citizens now fully inoculated with single-dose vaccine course, while 170M American peoples have been fully inoculated with the firm’s two-dose shots.

Furthermore, Moderna submitted a request seeking approval for an extra dose in September, and the FDA panel would hold a meeting on 14th October to discuss the booster shot.

Read Also: Should People Receive a Coronavirus Booster Shot Now?