2nd COVID-19 vaccine set for OK in the US with panel approval

WASHINGTON (AP) – A government advisory committee approved a second COVID-19 vaccine on Thursday, paving the way for the injection to be added to the US vaccination campaign.

The Food and Drug Administration is expected to follow the recommendation and rapidly 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 ages 18 and up.

Once emergency use authorization is granted, Moderna will begin shipping millions of doses, destined for healthcare workers and nursing home residents, to augment the largest vaccination effort in U.S. history.

The campaign began earlier this week with the first US approved vaccine developed by Pfizer and BioNTech. Moderna’s shot showed equally strong effectiveness, 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, nearly all participants supported the vaccine being made available to help fight the pandemic. One member of the jury abstained.

“The evidence that has been studied in great detail on this vaccine far outweighs 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 United States leads the world in virus numbers, with over 1.6 million confirmed cases and over 310,000 reported deaths.

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

Hopefully the two new vaccines will help “break the pandemic’s back,” said Dr Arnold Monto of the University of Michigan, who chaired the panel.

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

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

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

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

There were also three cases of Bell’s palsy, which temporarily paralyzes the facial muscles, among recipients of the vaccine, compared with only one among those who received a sham injection. The FDA review stated that the role of injection in the vaccine group “cannot be ruled out”.

An unanswered question is whether the vaccine also prevents people from infections without symptoms, but Moderna has come up with a suggestion that it might. Study participants were given a nose swab before the second dose of 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 starting to study its vaccine in children between the ages of 12 and 17. Tests on younger children are expected to begin early next year.

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

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

Hundreds of millions of additional injections will be needed to finally vaccinate the general public, which is not expected until spring or summer. The government’s Operation Warp Speed ​​program has ordered for 200 million doses of Moderna’s vaccine. This is on top of 100 million doses of the Pfizer-BioNTech vaccine. Officials are negotiating to buy more doses of that 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 duration of protection.

One of the more sensitive issues discussed by the speakers was how to prevent studio volunteers who received a dummy shot from dropping out to get the real shot. Their participation is essential to have a comparison in terms of long-term safety and efficacy.

Moderna proposed to immediately notify all those volunteers of their state and offer them the vaccine. The company said more than 25 percent of its participants are health care workers, and some are already heading off to get the Pfizer vaccine.

But Dr. Steven Goodman, an invited expert at Stanford University, suggested that Moderna take Pfizer’s approach. That company plans to gradually vaccinate people in its placebo group based on when they would normally have access to the vaccine, as priority groups are established.

But most speakers acknowledged that it will be difficult to prevent volunteers from leaving Moderna if they have to wait for a chance.

“The reality may make it too difficult to do,” said Dr. Steven Pergam of the Seattle Cancer Care Alliance.

Exactly how to treat study participants who received sham injections matters beyond ethics: Moderna noted that the only death from COVID-19 among 30,000 volunteers was in a placebo recipient, a 54-year-old man whose only risk factor was diabetes.

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

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Education. The AP is solely responsible for all content.

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