And Then There Were 2: Moderna Set to Join Pfizer-BioNTech with an Authorized COVID-19 Vaccine

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It seems like history is repeating itself from just a week ago. Yesterday, the U.S. Food and Drug Administration (FDA)’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended the agency grant Moderna’s COVID-19 vaccine emergency use authorization (EUA). The adcom voted 10 for, 0 against and 1 abstained. A week ago, the FDA granted Pfizer-BioNTech’s COVID-19 vaccine EUA on Friday the day after the same adcom voted 16-1-1. The Pfizer-BioNTech vaccine has since begun inoculations in the U.S.

If the agency approves today or tomorrow, Moderna will begin to ship about 5.9 billion doses starting this weekend. The Moderna vaccine and the Pfizer-BioNTech vaccine use very similar technology, a piece of mRNA that codes for a segment of the coronavirus’s spike “S” protein. The mRNA is encapsulated in a tiny fat molecule called a nanolipid particle. When it is injected into the body, it tells the cells to churn out the S protein, which programs the body’s immune system to identify and destroy the virus if it comes into contact with it. Both vaccines have demonstrated efficacy in clinical trials ranging from about 94 to 95%.

The Pfizer-BioNTech vaccine requires extremely cold temperatures for storage, about -94 degrees F, while the Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F.

“Moderna can go to more places,” Mandy Cohen, North Carolina’s secretary of health and human services, stated this week. “We hope to be in all 100 counties with some amount of vaccine—small allocations at first—by the end of next week, assuming Moderna gets approved this week and we get our allocations delivered over the course of next week.”

Pfizer-BioNTech had original plans to roll out 100 million vaccines globally by the end of this year, but are now saying 50 million. They still believe they can manufacture about 1.3 billion in 2021, enough for about 650 million people. The downgrade of this year’s 100-million-dose goal to 50 million was caused by supply-chain issues.

Moderna has said it believes it will have 20 million doses—enough for 10 million people—available by the end of the year and should be able to produce between 500 million and 1 billion doses in 2021.

Both vaccines require two doses about 28 days apart.

Unlike Pfizer-BioNTech, which accepted no development monies from the U.S. government’s Operation Warp Speed, Moderna has been working with the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID). The U.S. government provided almost $1 billion for research and other preparations while agreeing to acquire 200 million doses for about $3.1 billion. The U.S. government, though not funding Pfizer-BioNTech’s research, did buy $1.95 billion worth of vaccines.

To date, the research into the vaccines indicates it prevents symptomatic COVID-19 and appears to prevent severe disease. It is not clear yet if it can prevent infections from asymptomatic vaccinated people. Nor is it yet known how long the vaccine’s effects last. It may require a yearly booster.

State health officials learned that the second shipment of the Pfizer-BioNTech vaccine will be smaller than the first, which has raised questions about whether the Pfizer-BioNTech program will hit the U.S. government’s goal of providing 20 million people an initial dose before the end of the year. The delay seemed to be related to scheduling problems, although there have also been supply chain issues and a major winter storm on the east coast. Rough spots should probably be expected, given that it is the largest mass inoculation program in the history of the U.S. and the world.

Unlike the Pfizer-BioNTech vaccine, which was authorized for children 16 and 17 years of age, the Moderna vaccine, if authorized, will be for 18 and up—they did not request authorization for the younger age group because they did not have data on it. The adcom noted that the Moderna vaccine worked well in different segments of the clinical trials defined by race, ethnicity, gender and age.

There have been reports of severe allergic reactions to the Pfizer-BioNTech vaccine, two in the UK and one in the U.S.—there were two in Alaska, but only one was considered severe. All have recovered or are recovering. There are no apparent reports yet of allergic reactions to the Moderna vaccine during the clinical trials. The vaccines are similar but not identical and it’s still not clear what component of the Pfizer-BioNTech vaccine caused the allergic reactions, although most experts think it’s likely to be polyethylene glycol (PEG), a molecule used to coat the nanolipid particle in the Pfizer-BioNTech vaccine.

Both vaccines’ clinical trials reported a small number of cases of Bell’s Palsy, a temporary facial paralysis associated with viral infections and can occur at any age, but is most common in people between ages 16 and 60. It is temporary and is caused by the nerves that control facial muscles becoming inflamed, swollen or compressed. The Moderna trial reported three cases in the vaccine group and one in the placebo group, while Pfizer-BioNTech reported four cases, all in the vaccine group. FDA reviewers didn’t believe the palsy was related to the vaccine, partly because the number of cases was consistent—and even a little bit lower—than what would be expected in the normal population.

Otherwise, side effects are typical of all vaccines—soreness at the injection site, fatigue, achiness, occasionally fever and chills. Not all people experience these side effects.

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