Modern COVID-19 vaccine is ready for US green light after FDA advisory board approval

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

The Food and Drug Administration is expected to follow the recommendation and quickly accept 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 years and older.

Once the emergency use permit is granted, Moderna will begin transporting millions of doses to health care workers and nursing home residents to stimulate the largest vaccination effort in U.S. history.

The campaign began earlier this week with the first OK’d vaccine in the US, developed by Pfizer and BioNTech. Moderna’s move showed similar efficiency, providing 94% protection against COVID-19 in the company’s ongoing study of 30,000 people.

After seven hours of debating the technical details of the company’s study and follow-up plans, almost all members supported the provision of the vaccine to help fight the pandemic. A member of the committee abstained.

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

A second vaccine is urgently needed, as coronavirus infections, hospitalizations and deaths rise to new highs before the holidays. The US leads the world in total viruses, with over 1.6 million confirmed cases and over 310,000 reported deaths.

The Modern Vaccine uses the same revolutionary technology as Pfizer-BioNTech’s shot. Most traditional vaccines use dead or weakened viruses, but both new vaccines use fragments of the COVID-19 genetic code to train the immune system to detect and fight the virus. Both require two doses; Moderna’s is four weeks away.

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

Thursday’s review came days after apparent allergic reactions to the Pfizer-BioNTech vaccine were reported in two Alaska health workers. One person had a severe reaction, including difficulty breathing, the other had less serious side effects, including dizziness.

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

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

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

There have also been three cases of Bell’s palsy, which temporarily paralyzes the facial muscles among vaccine recipients, compared to only one of those who received a fake blow. The FDA said the role of the shot in the vaccine group “cannot be ruled out.”

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

Moderna is just beginning to study her vaccine in children between the ages of 12 and 17. Testing in younger children is expected to begin early next year.

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After the FDA acted, US officials plan to move an initial shipment of nearly 6 million doses of Moderna. The vaccine should be stored at normal freezer temperatures, but not at the ultra-cold required for the Pfizer-BioNTech shot.

With the addition of the Moderna vaccine, government officials project that 20 million Americans will be able to receive the first shots by the end of December and another 30 million in January.

Hundreds of millions of additional photos will be needed to eventually vaccinate the general public, which is not expected until spring or summer. The government’s Operation Warp Speed ​​program has orders for 200 million doses of Modern vaccine. This is over 100 million doses of Pfizer-BioNTech vaccine. Officials are negotiating to buy more doses of that vaccine and there are several vaccines in progress.

Like the first vaccine, Moderna’s will remain experimental, as the company continues a two-year study needed to answer key questions, including how long the protection lasts.

One of the most difficult topics discussed by the panel members was how to keep study volunteers who received a fake hit from giving up to get the real hit. Their participation is essential to have a comparison for long-term safety and efficacy.

Moderna proposed to immediately alert all those volunteers about their status and offer them the vaccine. The company said more than 25% of its participants are health workers, and some are already leaving to receive the Pfizer vaccine.

But Dr. Steven Goodman, a guest expert at Stanford University, suggested that Moderna take Pfizer’s approach. This company intends to gradually vaccinate people in its placebo group based on when they would normally have had access to the vaccine, as priority groups are set.

But most members of the panel acknowledged that it will be difficult to prevent volunteers from leaving the Moderna study if they have to wait to get hit.

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

Exactly how to treat trial participants who received unexplained photos is important beyond ethics: Moderna mentioned that the only COVID-19 death of the 30,000 volunteers was in a placebo recipient, a 54-year-old man whose only factor at risk was diabetes.

Knowing that there could be more severe coronavirus in patients receiving placebo, because the ongoing pandemic “weighs me down a lot,” Miller said of Moderna.

Copyright © 2020 by The Associated Press. All rights reserved.