WASHINGTON (AP) – A government advisory panel on Thursday approved a second COVID-19 vaccine, paving the way for the injection to be included in the US vaccination campaign.
The Food and Drug Administration is expected to follow up on the recommendation and promptly approve the Moderna and National Institutes of Health vaccine. FDA advisers agreed 20-0 that the benefits of the vaccine outweighed its risks for those 18 and older.
Once emergency use permission is granted, Moderna will begin sending millions of doses to health professionals and nursing home residents to drive the largest vaccination effort in US history.
The campaign began earlier this week with the first vaccine OK’d in the US, developed by Pfizer and BioNTech. The inclusion of Moderna showed equally effective effectiveness, providing 94% protection against COVID-19 in the company’s ongoing study of 30,000 people.
After eight hours of discussion about technical details of the study and the company’s follow-up plans, nearly all panelists supported making the vaccine available to help combat the pandemic. One panel member abstained.
“The evidence that has been studied in 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 before the holidays soar to new highs. The US leads the world in virus totals, with more than 1.6 million confirmed cases and more than 310,000 deaths reported.
Moderna’s vaccine uses the same breakthrough technology as the Pfizer-BioNTech shot. Most traditional vaccines use a dead or attenuated virus, but both new vaccines use fragments of the COVID-19 genetic code to train the immune system to detect and fight the virus. Both need two doses; Moderna’s is four weeks apart.
The two new vaccines will hopefully help “break the pandemic,” said Dr. Arnold Monto of the University of Michigan, who chaired the panel.
Thursday’s review came days after reports of apparent allergic reactions to the Pfizer-BioNTech vaccine in two health professionals in Alaska. One person had a serious reaction, including shortness of breath, the other had less serious side effects, including dizziness.
Although the two vaccines use the same technology, they are not identical, Dr. Tal Zaks, Moderna’s Chief Medical Officer. In particular, some of the lipids or fats used to coat the two vaccines are different.
“I wouldn’t necessarily assume” that all responses would be the same, he said.
The FDA did not find any serious allergic reactions in Moderna’s data, but noted a slightly higher number of less serious side effects – rash, hives, itching – among participants who received the vaccine, compared to those who received a fake shot.
There were also three cases of Bell’s palsy, which temporarily paralyzes facial muscles, among vaccine recipients, compared with just one in those who received a fake shot. The role of the injection in the vaccine group “cannot be ruled out”, according to the FDA review.
An unanswered question is whether the vaccine will also prevent people from getting symptom-free infection – but Moderna found a hint that this is possible. The study participants had their noses wiped before the second dose of vaccine or placebo. At that one time point, smears from 14 vaccine recipients and 38 placebo recipients showed signs of asymptomatic infection, said Dr. Jacqueline Miller from Moderna.
Moderna has just started studying the vaccine in children ages 12 to 17. Testing in younger children is expected to start early next year.
After the FDA acted, US officials plan to move an initial shipment of nearly 6 million Moderna doses. The vaccine should be stored at normal freezing temperatures, but not the ultra cold required for Pfizer-BioNTech uptake.
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 30 million more by January.
Hundreds of millions of additional shots 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 Moderna’s vaccine. That’s in addition to 100 million doses of the Pfizer BioNTech vaccine. Officials are negotiating to buy more doses of that vaccine and more vaccines are in the pipeline.
Like the first vaccine, Moderna’s will remain experimental as the company continues a two-year study needed to answer important questions, including duration of protection.
One of the trickiest issues panelists discussed was how to prevent study volunteers who were given a dummy recording from dropping out to get the real recording. Their participation is critical to have a comparison for long-term safety and effectiveness.
Moderna suggested that all those volunteers should be immediately informed of their status and offered them the vaccine. The company said more than 25% of the participants are health professionals and some are already leaving to receive the Pfizer vaccine.
But Dr. Steven Goodman, an invited expert from Stanford University, suggested Moderna adopt Pfizer’s approach. That 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 being established.
But most panelists acknowledged that it will be difficult to prevent volunteers from leaving the Moderna study if they have to wait to have a chance.
“Reality may make that too difficult to do,” said Dr. Steven Pergam of the Seattle Cancer Care Alliance.
Exactly how the trial participants who received dummy shots should be treated is important outside of ethics: Moderna noted that the only COVID-19 death among the 30,000 volunteers was in a placebo recipient, a 54-year-old male whose only risk factor diabetes.
Knowing that there could be a more serious coronavirus in placebo recipients as the pandemic continues “weighs heavily on me,” Moderna’s Miller said.
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The Associated Press Health and Science Department is supported by the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.