Moderna Could Have Omicron Booster Shot Ready to File for FDA Authorization by March

Moderna Could Have Omicron Booster Shot Ready to File for FDA Authorization by March
A vial of the Moderna COVID-19 vaccine is seen at a local clinic in Aschaffenburg, Germany, on Jan. 15, 2021. (Kai Pfaffenbach/Reuters)

Moderna President Stephen Hoge said Wednesday that the company could have a COVID-19 booster shot to combat the newly-discovered Omicron variant tested and ready to file for U.S. authorization as soon as March.

Boosters carrying genes specifically to combat mutations in the variant could be the quickest way to address any effect it may have on the potency of vaccines, Hoge told Reuters.

“We’ve already started that program,” he said, adding that “the Omicron-specific boosters, just realistically, are not [going to be ready] before March and maybe more in the second quarter,” unless the Food and Drug Administration (FDA) changes its guidance regarding the data needed for authorization.

The company would be able to manufacture the vaccine while simultaneously conducting testing to make sure it is ready to roll out as quickly as possible, Hoge explained.

Moderna has joined the world’s major manufacturers of COVID-19 vaccines in the race to investigate the new Omicron variant and adapt their shots to combat the new strain, which has a high number of mutations and appears to spread rapidly.

The pharmaceutical and biotechnology company based in Cambridge, Massachusetts, said it is also working on a multi-valent vaccine capable of protecting against multiple diseases or strains of a single pathogen.

The vaccine would include up to four different coronavirus variants including Omicron and could take several more months to create, Hoge said.

Speaking on the BBC’s “Andrew Marr Show” on Sunday, Moderna’s Chief Medical Officer Paul Burton said that large quantities of a new and reformulated vaccine to combat the newly identified variant could be available early next year.

The company is currently testing a higher dose of its current vaccine against the Omicron variant, which was discovered in South Africa in November.

Burton noted that scientists and researchers are still “really trying to work out” the new variant and establish whether or not it is more transmissible, how severe its side effects are, and how they can contain and control it with the currently available vaccines; the latter of which researchers should know within a couple of weeks after conducting laboratory experiments.

“We should know about the ability of the current vaccine to provide protection in the next couple of weeks,” Burton said. “If we have to make a brand new vaccine, I think that’s going to be early 2022 before that’s really going to be available in large quantities,” he added.

The chief medical officer acknowledged that the new variant contains multiple mutations, with “at least 30 of them in the spike protein alone, nine of them known to be associated with immune escape,” and “another 11 predicted to be associated with immune escape.”

“You bring those together [and] I think this is a very concerning virus,” he said while urging people to get vaccinated.

Travelers queue at check-in counters at OR Tambo International Airport in Johannesburg, on Nov. 27, 2021. (Phill Magakoe/AFP via Getty Images)
Anthony Fauci
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and the Chief Medical Advisor to the President, delivers an update on the Omicron COVID-19 variant during the daily press briefing at the White House on Dec. 1, 2021. (Anna Moneymaker/Getty Images)

Hoge told Reuters on Wednesday that he still believes that the existing vaccines “will be able to at least slow down, if not completely stop, the Omicron variant.”

Officials announced on Nov. 30 that the first case of the Omicron variant had been discovered in the United States.

Genomic sequencing conducted at the University of California–San Francisco and reviewed by CDC scientists confirmed that the case is caused by the new COVID-19 variant.

The patient traveled from South Africa on Nov. 22, began experiencing symptoms on Nov. 25, and tested positive for COVID-19 on Nov. 29. The person, a San Francisco resident who hasn’t been publicly identified, is self-isolating. They are fully vaccinated. They are said to be experiencing mild symptoms that are improving, officials have said.

On Wednesday, Dr. Anthony Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases, advised the public to “get boosted now” because “we may not need a variant-specific boost” but noted that the Biden administration is preparing for the possibility that a booster shot may be needed and has been in contact with the pharmaceutical companies developing COVID-19 vaccines.

From The Epoch Times

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