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 over 18 years of age.
Once the emergency use permit is granted, Moderna will begin shipping millions of doses, aimed at health care workers and residents of residences, to increase the largest vaccination effort in U.S. history.
The campaign began earlier this week with the first OK’d vaccine in the United States, developed by Pfizer and BioNTech. Moderna’s shooting showed similar effectiveness, providing 94% protection against COVID-19 in the company’s ongoing study of 30,000 people.
After seven hours of discussion about the technical details of the study and the company’s follow-up plans, nearly all panelists supported making the vaccine available to help fight the pandemic. A member of the court abstained.
“The evidence that has been studied in detail about this vaccine far outweighs 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 United States leads the world in terms of viruses, with more than 1.6 million confirmed cases and more than 310,000 reported deaths.
The Moderna vaccine uses the same innovative technology as the Pfizer-BioNTech feature. 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 is four weeks apart.
Hopefully, 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 Alaska health workers. One person had a severe reaction, including difficulty breathing, and the other had less severe side effects, including dizziness.
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Although the two vaccines use the same technology, they are not identical, warned Moderna’s 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 any reaction would be the same, he said.
The FDA found no severe allergic reactions to Moderna’s data, but marked a slightly higher rate of less severe side effects (rash, hives, itching) among participants who received the vaccine, compared with who received a fictitious shot.
There were also three cases of Bell’s palsy, which temporarily paralyzes the facial muscles, between vaccine receptors, compared to only one of those who received a fictitious shot. The FDA review 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 getting asymptomatic infection, but Moderna found a clue that it could be. Study participants had their noses cleaned before the second dose of vaccine or placebo. At that time, swabs from 14 vaccine receptors and 38 placebo receptors showed evidence of asymptomatic infection, said Dr. Modern, Jacqueline Miller.
Modern is beginning to study its vaccine in children aged 12 to 17 years. Testing in younger children is expected to begin early next year.
SEE: What are the side effects of COVID-19 vaccines?
Following FDA acts, U.S. officials plan to move an initial shipment of about 6 million doses of Moderna. The vaccine should be stored at normal temperatures in the freezer, but not at the ultra-cold temperature required for Pfizer-BioNTech firing.
With the incorporation of the Moderna vaccine, government officials project that 20 million Americans will be able to receive their first shots by the end of December and another 30 million in January.
Hundreds of millions of additional shots will be needed to end up vaccinating 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 exceeds 100 million doses of the Pfizer-BioNTech vaccine. Officials are negotiating the purchase of more doses of this vaccine and there are more vaccines underway.
Like the first vaccine, Moderna will remain experimental as the company continues a two-year study needed to answer key questions, including the duration of protection.
One of the most complicated topics discussed about the panelists was how to prevent studio volunteers who received a fictitious shot from giving up on getting the real shot. Their participation is key to being able to compare safety and long-term effectiveness.
Moderna proposed to immediately alert all volunteers in her state and offer them the vaccine. The company said more than 25% of its participants are health workers and some are already leaving to get the Pfizer vaccine.
But Dr. Steven Goodman, a guest expert at Stanford University, suggested that Moderna take Pfizer’s approach. This 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 set.
But most panelists acknowledged that it will be difficult to prevent volunteers from leaving Moderna’s studio if they have to wait to get a chance.
“Reality can make it too hard to do,” Dr. Steven Pergam of the Seattle Cancer Care Alliance.
Exactly how to treat trial participants who received fictitious shots is important beyond ethics: Modern noted that the only death from COVID-19 among the 30,000 volunteers was in a placebo receptor, a 54-year-old man whose only risk factor was diabetes.
Knowing that there could be more serious coronaviruses in placebo receptors as the pandemic continues “weighs heavily on me,” Miller de Moderna said.
Copyright © 2020 by The Associated Press. All rights reserved.