US FDA clears Moderna, J&J COVID-19 boosters, supports use of different vaccines for boost – .

US FDA clears Moderna, J&J COVID-19 boosters, supports use of different vaccines for boost – .

October 20 (Reuters) – The United States Food and Drug Administration on Wednesday cleared booster doses of the COVID-19 vaccines from Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N), and said the Americans can choose a shot different from their original inoculation as a booster.

This means that the three vaccines licensed in the United States can also be given as boosters to certain groups.

“The availability of these licensed boosters is important for continued protection against COVID-19 disease,” FDA Acting Commissioner Janet Woodcock said in a statement. She noted that the data suggests that the vaccine’s effectiveness may decrease over time in some people who are fully vaccinated.

The move paves the way for millions of people in the United States to gain additional protection, as the highly contagious Delta variant of the virus causes groundbreaking infections in some who are fully vaccinated.

The agency had previously cleared recalls of Pfizer Inc’s COVID-19 vaccine (PFE.N) developed with German partner BioNTech SE (22UAy.DE) at least six months after the first round of shots to increase protection for the elderly 65 years and over, those at risk of serious illness and those who are exposed to the virus in the course of their work.

Last week, an FDA advisory group voted to recommend a third round of Moderna vaccines for the same groups. Moderna’s booster is half the strength of the injections given for the company’s initial round of inoculations. Read more

The panel also recommended a second injection of the J&J vaccine for all recipients of the inoculation in one dose at least two months after receiving the first.

FDA officials suggested last week that they consider lowering the recommended age for booster shots of the Pfizer / BioNTech vaccine to age 40, based on data from Israel, where injections of Pfizer booster have already been administered extensively.

They did not lower the age range for injections on Wednesday, but said they were weighing the benefits and risks of using the boosters more widely and planning to inform the public in the coming weeks.

“There is evidence that potentially suggests that lowering the ages of those eligible for recalls may make sense in the future,” FDA official Peter Marks told a news conference. “It’s something we’re looking at closely. “


The FDA and the U.S. Centers for Disease Control and Prevention (CDC) were under pressure to allow the additional injections after the White House in August announced plans for a massive recall campaign.

The advisory group meeting included a presentation of vaccine mix data from a US National Institutes of Health study in which 458 participants received a combination of Pfizer / BioNTech, Moderna and J&J vaccines.

Data showed that people who initially received J & J’s COVID-19 vaccine had a stronger immune response when stimulated with the Pfizer or Moderna vaccine, and that ‘mix and match’ booster shots of different types were safe in adults. Read more

Still, FDA officials said the data was not yet clear on whether a combination fire was to be preferred.

“Because we don’t have that data right now, I think we just need to not commit to what’s best,” Marks said.

Many countries, including the UK, have supported mix-and-match strategies for the widely used AstraZeneca Plc (AZN.L) vaccine, which is not licensed in the US but is based on viral vector similar to that of the J&J vaccine.

Reuters reported in June that infectious disease experts were assessing the need for Pfizer or Moderna vaccine booster vaccines after the J&J vaccine. Read more

A CDC advisory committee will make recommendations on Thursday on which groups of people should get the Moderna and J&J boosters, which the agency director will use to inform his final decision.

About 11.2 million people have so far received a booster dose, according to CDC data.

Reporting by Ankur Banerjee in Bengaluru and Michael Erman in New Jersey; Editing by Bill Berkrot and Peter Cooney

Our Standards: The Thomson Reuters Trust Principles.


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