FDA Advisers Recommend Emergency Authorization for Moderna Vaccine

A nurse prepares a shot for a Covid-19 vaccine developed by the National Institutes of Health and Moderna Inc. in Binghamton, N.Y., this past summer. (AP Photo/Hans Pennink, File)

(CN) — A second Covid-19 vaccine was recommended for emergency use by advisers to the Food and Drug Administration on Thursday, meaning distribution nationwide could start as soon as next week.

The respiratory disease caused by the novel coronavirus has claimed the lives of 300,000 Americans and counting since the pandemic began, with over 17 million total infections, according a Johns Hopkins University tracker.

But the light at the end of the tunnel grows brighter with Moderna’s vaccine closer to joining Pfizer-BioNTech’s in receiving emergency use authorization from the FDA. Thursday’s recommendation from the advisory panel could be adopted by the agency as soon as Friday, with immediate distribution following.  

Last week, the Pfizer vaccine – which is 95% effective against the novel coronavirus – was approved for people 16 and up by the FDA after a recommendation from the agency’s independent Vaccines and Related Biological Products Advisory Committee.

Moderna’s vaccine is 94.1% effective and was recommended for approval with similar considerations for risk as Pfizer’s. Both vaccines had to meet certain criteria before approval could be granted, including demonstrating that it is effective at preventing or treating Covid-19 and that the benefits outweigh the risks.  

There have been reports of allergic reactions in a small number of individuals who received the vaccine from either company so far, but all of them had a history of serious allergic reactions. Researchers on the committee acknowledged Thursday their reactions had not been to any of the components found in the vaccine.

While the reactions aren’t unusual, FDA vaccine expert Doran Fink a close eye will be kept on other incidents that might crop up. The agency’s Vaccine Adverse Event Reporting System will help officials track allergic reactions around the nation.

“We anticipate additional reports, and we will rapidly investigate,” Fink vowed, adding the FDA will eventually issue recommendations regarding the vaccines and allergic reactions.

While most members of the advisory board voted in favor of moving Moderna’s vaccine closer toagency approval, one member, Michael Kurilla, director of clinical innovation at the National Institutes of Health, abstained.

“With limited vaccine supply available, a blanket statement for candidates 18 years and old – I’m not convinced for all of those age groups the benefits do outweigh the risk, and I’d like to see it more targeted to people with serious or life-threatening Covid disease,” Kurilla said. “I would have preferred to have seen, rather an emergency use authorization, an expanded access program that would have given us a lot more opportunity to collect the data.”

Emergency use authorization can be revised or revoked at any time if new concerns arise about safety, effectiveness, manufacturing or quality. But the FDA advisers are encouraged that the vaccines whipped up in record time are the key to returning to pre-pandemic life.

The vaccines stimulate an immune response in humans through a technique using RNA, a type of molecule found in human cells. The messenger RNA, or mRNA, instructs cells to produce a spiky coronavirus-like protein which in turn prompts the body’s immune system to respond and defend itself.

Conspiracies floating around suggesting that the vaccine could somehow alter a person’s DNA are patently false and actually impossible with the way the vaccine is constructed, according to Melissa Moore, chief scientific officer for Moderna’s research platform.

“The vaccine has no capacity to alter DNA. It is transient and remains in cytoplasm until it is eliminated naturally. To alter it, [the mRNA] would have to gain access to the nucleus of a cell and reverse transcribe. Our mRNA contains no signals for nuclear access or reverse transcription,” Moore said at Thursday’s board meeting.

While confidence is high, some questions remain: Will the vaccine stop transmission of Covid-19 in its tracks? Will the virus mutate and find a way to evade its demise by inoculation? And what about clinical trial participants who still contracted the virus even after being dosed?

Jacqueline Miller, Moderna’s senior vice president of infectious disease, told the committee Thursday that those answers will not be known until further review.

According to Moderna, only 11 people who received the vaccine over its recommended two doses became infected with novel coronavirus after the fact. There were 185 people in the placebo group who contracted the virus, demonstrating the vaccine’s efficacy. 

Virologist Paul Offit, who works at the Children’s Hospital of Philadelphia, said the 11 subjects who still contracted Covid-19 after being vaccinated could provide valuable information on the limits of the human body’s immunity to the virus.

While their antibodies were not enough to overcome infection, by calculating just how few antibodies were produced in each person, scientists can understand what the immunity baseline is and increase effectiveness of the vaccine over time.

Patrick Moore, a virologist at the University of Pittsburgh School of Medicine, said antibodies not being effective in the 11 test subjects could indicate a virus mutation. Only more testing and review will confirm or deny that hypothesis.

For now, side effects from the Moderna and Pfizer vaccines have been mostly limited to common ailments like fatigue, headache, body ache or muscle pain. Just three people in Pfizer’s test group developed short-lived Bell’s palsy symptoms, or drooping of the face. One person in Pfizer’s placebo group developed it too. 

There are 63 vaccines currently in clinical trial and 18 are in their final rounds of evaluation. Over 85 pre-clinical trials are underway in animals.

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