Moderna COVID-19 vaccine set to get US green light after FDA advisory board approval

WASHINGTON – A government advisory group approved a second COVID-19 vaccine on Thursday, paving the way for the vaccine to be added to the U.S. vaccination campaign.

The Food and Drug Administration should follow the recommendation and quickly approve the vaccine from Moderna and the National Institutes of Health. FDA advisers, in a 20-0 vote, agreed that the benefits of the vaccine outweighed the risks for those 18 and older.

Once emergency use authorization is granted, Moderna will begin shipping millions of doses, intended for health workers and nursing home residents, to boost the largest vaccination effort in state history. -United.

The campaign kicked off earlier this week with the first OK’d vaccine in the United States, developed by Pfizer and BioNTech. Moderna’s shot showed similar effectiveness, providing 94% protection against COVID-19 in the company’s ongoing study of 30,000 people.

After seven hours of debate on the technical details of the company’s study and follow-up plans, nearly all panelists supported making the vaccine available to help fight the pandemic. A panel member abstained.

“The evidence that has been studied in detail on this vaccine far outweighs any problems that we have seen,” said Dr. Hayley Gans of Stanford University Medical Center.

A second vaccine is urgently needed as coronavirus infections, hospitalizations and deaths reach new highs ahead of the holidays. The United States leads the world in virus totals, with more than 1.6 million confirmed cases and more than 310,000 reported deaths.

Moderna’s vaccine uses the same revolutionary technology as Pfizer-BioNTech’s vaccine. Most traditional vaccines use dead or weakened viruses, but the two newer vaccines use extracts of the COVID-19 genetic code to train the immune system to detect and fight the virus. Both require two doses; Moderna is four weeks apart.

We hope the two new vaccines will help “break the back of the pandemic,” said Dr. Arnold Monto of the University of Michigan, who chaired the group.

Thursday’s review came days after reports of apparent allergic reactions to the Pfizer-BioNTech vaccine in two Alaskan health workers. One person had a severe reaction, including shortness of breath, the other had less serious side effects, including dizziness.

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Although the two vaccines use the same technology, they are not identical, warned Moderna chief medical officer Dr Tal Zaks. In particular, some of the lipids, or fats, used to coat the two vaccines are different.

“I wouldn’t necessarily assume” that all reactions would be the same, he said.

The FDA found no serious allergic reactions in the Moderna data, but reported a slightly higher rate of less serious side effects – rashes, hives, itching – among participants who received the vaccine, compared to those who received a fake vaccine.

There have also been three cases of Bell’s palsy, which temporarily paralyzes the muscles of the face, among those vaccinated, compared to only one among those who received a dummy vaccine. The FDA review stated that the role of the vaccine in the vaccine group “cannot be ruled out”.

An unanswered question is whether the vaccine also prevents people from getting asymptomatic infections – but Moderna has found a clue that it can. Study participants had their noses swabbed before the second dose of the vaccine or placebo. At that time, swabs from 14 vaccinated and 38 placebo recipients showed signs of asymptomatic infection, said Dr Jacqueline Miller of Moderna.

Moderna is just starting to study its vaccine in children aged 12 to 17. Testing of young children is expected to begin early next year.

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After the actions of the FDA, US officials plan to move a first shipment of nearly 6 million doses of Moderna. The vaccine should be stored at regular freezing temperatures, but not in the ultra-cold required for injection of Pfizer-BioNTech.

With the addition of Moderna’s vaccine, government officials predict that 20 million Americans will be able to receive their first vaccines by the end of December and 30 million more in January.

Hundreds of millions of additional vaccines will be needed to eventually vaccinate the general public, which is only expected in the spring or summer. The government program Operation Warp Speed ​​has ordered 200 million doses of Moderna vaccine. This is in addition to 100 million doses of the Pfizer-BioNTech vaccine. Authorities are negotiating to buy more doses of this vaccine and there are more vaccines in the pipeline.

Like the first vaccine, Moderna will remain experimental as the company continues a two-year study needed to answer key questions, including length of protection.

One of the trickiest questions discussed by the panelists was how to prevent study volunteers who received a dummy injection from giving up to get the real photo. Their participation is essential in order to be able to compare safety and long-term efficacy.

Moderna offered to immediately alert all these volunteers of their status and offer them the vaccine. The company said more than 25% of its attendees were health workers, and some were already leaving to be vaccinated by Pfizer.

But Dr. Steven Goodman, a visiting expert from Stanford University, suggested Moderna take the Pfizer approach. The company plans to gradually vaccinate people in its placebo group based on when they would normally have had access to the vaccine, as priority groups are established.

But most panelists acknowledged that it will be difficult to prevent volunteers from leaving the Moderna study if they have to wait for a photo.

“Reality can make this too difficult to do,” said Dr. Steven Pergam of the Seattle Cancer Care Alliance.

How exactly to treat trial participants who received dummy injections is important beyond ethics: Moderna noted that the only death from COVID-19 among the 30,000 volunteers was in a placebo recipient, a 54-year-old man whose only risk factor was diabetes.

Knowing that there could be a more serious coronavirus in placebo recipients as the pandemic continues “weighs heavily on me,” said Moderna’s Miller.