WASHINGTON: Johnson & Johnson requested feeding for food and drugs on Tuesday to allow extra shots of Covid-19 vaccine as the US government to move towards expanding its booster campaign to millions of Americans more vaccinated.
J & J said it was a request with the FDA to ratify the booster for people who had previously received a one-shoot vaccine company.
While the company said it sent data on several different booster intervals, ranging from two to six months, it did not officially recommend one to the regulator.
Last month, the FDA authority of the Booster Shots Vaccine Pfizer for older Americans and other groups with high vulnerability to Covid-19.
This is part of an effort to sweep by the Biden government to protect protection in the middle of the Delta variant and the potential of vaccine immunity decreases.
The government adviser supports additional Pfizer shots, but they are also worried about creating confusion for tens of millions of other Americans who receive modern shooting and J & J.us.
Officials do not recommend mixing and matching various brand vaccines.
The FDA holds an external advisor panel next week to review Booster data from J & J and Moderna.
This is the first step in the review process which also includes registration of FDA leadership and control centers and prevention of disease.
If both institutions provide headlights, Americans can start making J & J and modernum booster this month.
The J & J data released previously showed its vaccine remained very effective against Covid-19 at least five months after vaccination, showed 81% effectiveness against hospitalization in Thus but the company’s research showed a dose of booster in two or six months struggling further.
The FDA advisor will review the data next Friday and vote whether to recommend Boosters.
The time of J & J’s archiving is unusual given that the FDA has scheduled its meeting on company data.
The company usually sends their requests long before the announcement of the meeting.
The J & J executive said the company had worked with the FDA on the review.
“Whether J & J and the FDA have a sense of urgency because of Covid and we want good data out there converted to act as soon as possible,” said Dr.
Mathai Mammen, Head of Research J & J Janssen Unit.
The new vaccine of Brunswick, New Jersey, the company is considered an important tool in fighting a pandemic because it only requires one shot.
But the launch was injured by a series of problems, including the problem of manufacturing at the Baltimore factory which forced J & J to import millions of doses from abroad.
In addition, regulators have added a warning of several rare side effects on shots, including blood clot disorders and neurological reactions called Guillain-Barré syndrome.
In both cases, the regulator decided the benefits of the shot still exceeded the unusual risk.
Whereas of Pfizer and Moderna Salinganmaker has provided the majority of US vaccines Covid-19.
More than 170 million Americans have been fully vaccinated with a two-dose firm shot while less than 15 million Americans get J & J shots.