Moderna is seeking FDA approval for omicron variant-specific booster shots

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Moderna said it would seek authorization for an updated coronavirus vaccine designed to protect against omicron subvariants that the company described as its “leading candidate” for a fall booster, but it is still unclear how effective the shot will be against the latest versions of the omicron variant . spreads in the United States.

Preliminary data released by the company on Wednesday showed that its omicron-targeted coronavirus booster candidate produced 1.75 times as many neutralizing antibodies to the version of omicron that circulated over the winter, known as BA.1, compared to the existing vaccine.

But the omicron variant has mutated so rapidly that several new sub-variants have emerged that are even better at escaping the immune system’s defenses. Two of these, known as BA.4 and BA.5, are now responsible for 13 percent of new coronavirus cases in the United States, the Centers for Disease Control and Prevention said in new estimates. It is unclear whether BA.4 and BA.5 will become dominant in the coming months or whether existing immunity in the population against infections and vaccinations will curb the spread.

Biden administration officials have said they are preparing for a fall and winter wave that could see 100 million coronavirus infections and a potentially significant number of deaths, driven by omicron subvariants. This makes it even more important that more effective vaccines are available, especially to protect the elderly and most vulnerable.

Modern leaders said in a telephone conversation on Wednesday that they are confident that the updated vaccine will still provide extra protection against newer omicron sub-variants, even though researchers tested the booster dose against BA.1. Although updated booster provides less protection against later omicron sub-variants than against BA.1, it will probably still be more effective against them than the company’s existing booster, said Moderna president Stephen Hoge.

“We are pretty sure that this vaccine will give an advantage even to the family of omicron sub-variants,” Hoge said in a briefing with journalists.

Right after the omicron variant was identified in South Africa late last year, Moderna said that they developed shots specially designed to combat the variant. Pfizer and BioNTech announced the same plan, although they have not yet released data on their updated vaccine.

Moderna releases data to support the autumn vaccine strategy

Data from the recent clinical study, which involved 437 participants, showed that Moderna’s omicron-targeting booster would likely provide long-term protection against variants one month later, compared with previous versions of the coronavirus vaccine, Moderna said.

The booster “was generally well tolerated,” with side effects comparable to those of previous boosters, the company said.

The White House has been pushing Congress for more than $ 20 billion for the coronavirus response for several months. Legislators have not yet approved new funding.

The official number of new daily coronavirus infections is rising slowly in the United States, although the actual numbers are believed to be far higher because so many people are testing themselves at home. The country recorded a 38 percent increase in new cases over the past week, according to figures compiled by The Washington Post, as protection against booster shots and previous infections declines and more people go without masks.

Globally, new cases of coronavirus continue to decline after the omicron variant triggered tens of millions of new cases worldwide, spreading infections during the winter.