FDA review clears path for second coronavirus vaccine, this one developed by Moderna

The FDA is likely to authorize the vaccine as soon as Friday, according to a person with knowledge of the situation who spoke on the condition of anonymity because they were not authorized to speak on the issue. Anticipating that decision, Gen. Gustave Perna, who is overseeing the federal effort to develop and distribute vaccines, said Monday that the U.S. was preparing to ship almost 6 million doses of the Moderna vaccines to 3,285 locations in the first week.

“It will be a very similar cadence that was executed this week with Pfizer, where we’re hitting initial sites on Monday, follow on Tuesday and Wednesday,” Perna said.

Moderna’s vaccine will be reviewed Thursday by the same panel of independent experts at an all-day public meeting. The data it will consider echoes the evidence that led to a 17 to 4 vote to authorize the Pfizer-BioNTech vaccine, which was 95 percent effective. In addition, the two-shot Moderna regimen was particularly effective against severe disease. There were 30 cases of severe covid-19, the disease caused by the virus, in the trial, none of them in the group that got the vaccine.

Regulators also confirmed the Moderna vaccine worked well in people of all ages, races and genders. Side effects were widespread, occurring in most recipients, but typically short-lived, including fatigue, headaches, muscle aches and pain at the injection site.

One point of contention about the Pfizer-BioNTech vaccine — whether it should be authorized for use in 16- and 17-year-olds — will likely be avoided, because Moderna is only seeking clearance for its vaccine for use in people 18 and older. Last week, the company began testing its vaccine in adolescents.

Moderna developed its vaccine in partnership with the National Institute of Allergy and Infectious Diseases, with the government underwriting the research and development of the vaccine and the advanced purchase of 200 million doses, bringing the taxpayer investment to $4.1 billion.

The FDA reviews of both the Pfizer-BioNTech and Moderna vaccines cement the success of a new genetic vaccine technology, which could be used to rapidly create vaccines for other diseases.

Older vaccines work by injecting dead or weakened virus to teach the immune system to recognize the real pathogen. In contrast, the messenger RNA technology at the core of the Moderna and Pfizer-BioNTech vaccines delivers a strip of genetic material called RNA, encased in a fat bubble, to a person’s cells.

Once inside a cell, the messenger RNA co-opts the machinery used to make proteins to build tiny replicas of the spike protein that studs the outside of the coronavirus. The immune system learns to recognize — and block — the spike.

In Moderna’s trial, 30,000 people were randomly assigned to receive either two shots of a vaccine given four weeks apart, or two saline shots. Neither the participants, nor the people running the trial knew who was in which group. Investigators then waited as people were exposed to coronavirus in their daily lives, to see if there were more covid-19 infections in the group that did not receive the real vaccine.

The numbers were decisive: There were 196 cases in the trial, all but 11 of them in the group that received the placebo shots. There were 30 cases of severe covid-19, and one death from covid-19 in the trial, also all in the group that received the placebo shots.

There were three cases of Bell’s palsy, a temporary facial paralysis, in the group that received the Moderna vaccine, compared with one case in the placebo group. The people who developed Bell’s palsy had other risk factors, and the rate was similar to that expected in the general population. But the FDA concluded “a potential contribution of the vaccine to the manifestations of these events of facial palsy cannot be ruled out.”

A swelling of the vaccinated arm, lymphadenopathy, was more common in the group that received the vaccine, with 16 percent of participants experiencing the symptom after the second dose. There were no severe allergic reactions, a concern that has emerged after two cases were reported in the United Kingdom after the first injections of the Pfizer-BioNTech vaccine.

Enrollment in Moderna’s trial was slowed down this summer because scientists were concerned it lacked sufficient racial diversity to determine whether it truly protected those at highest risk of the disease. In the end, a fifth of participants were Hispanic, 10 percent were Black and four percent were Asian. More than 40 percent of the participants were either over the age of 65 or had medical conditions that increased their risk of severe disease.

“The trial enrolled the right people at risk,” said Larry Corey, a virologist at the Fred Hutchinson Cancer Research Center who co-leads the government’s clinical trial network responsible for testing coronavirus vaccines. “For us who were designing the trial and enrolling the people, that’s so fantastic.”

Laurie McGinley contributed to this story.

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