FDA Report Brings Moderna COVID-19 Vaccine One Step Closer to Approval

 The FDA has just released a sweeping new report on the safety and efficacy of the Moderna COVID-19 vaccine. This comes just two days before the agency’s Vaccine Advisory Committee will discuss whether the drug should be approved for emergency use in the U.S. It’s a clear sign that the vaccine will most likely get the green light from federal regulators, which means the first doses could go out as soon as next week.

A Strong Showing for Safety and Efficacy

In a detailed review of the drug, the FDA says the Moderna vaccine is both safe and effective at preventing serious illness related to COVID-19. Regulators said in the report that the vaccine has a “favorable safety profile” with “no specific safety concerns.” However, some patients have experienced mild side effects, including fatigue, headaches, and soreness at the injection site, all of which are commonly associated with vaccines.

The FDA has confirmed the safety information provided by Moderna, which says the drug is around 94% effective at preventing serious illness. The agency noted a dip in efficacy for patients over the age of 65. The FDA says the drug will only be 86% effective for these individuals.

What Does This Mean?

The review does not mean the drug has been approved for emergency use. It only means that federal regulators have found the drug to be both safe and effective. The FDA Vaccine Advisory Committee, which operates independently of the agency, is made up of highly respected doctors, epidemiologists, and public health experts. The review released today will likely influence the committee’s decision.

During the hearing, the committee will hear from Moderna representatives, FDA scientists, and various members of the public before issuing its verdict.

Once the committee issues its ruling, the FDA will then decide whether to approve the drug for emergency use.

If this sounds familiar, that’s because the Pfizer vaccine just went through this process last week. The FDA approved that drug for emergency use last Friday. It’s already been administered to thousands of healthcare workers and patients all over the world.   

Once approved for emergency use, the Moderna vaccine will be rolled out using methods similar to those developed by Pfizer. The first round of shipments could include as many 6 million doses, which could ship as soon as Monday.

The FDA Vaccine Advisory Committee will also decide who should get the drug first. It’s likely that the first shipments will be sent to frontline workers and nursing home residents who weren’t included in the first shipments of the Pfizer vaccine. Every patient must receive two doses, exactly twenty-one days apart, just like the Pfizer vaccine.

“This is great news, as this now brings us to two products with high levels of efficacy,” said Dr. Rupali Limaye, an associate scientist at Johns Hopkins Bloomberg School of Public Health.

How Does It Compare to Pfizer’s Vaccine?

Now that the coronavirus death toll in the U.S. has surpassed 300,000, providers need as many tools in their arsenal as they can find. Dr. Barry R. Bloom, a professor of public health at Harvard, says the results from Moderna and Pfizer were “extraordinarily comparable.” This gives providers two effective weapons against the spread of the virus as the number of new infections keeps climbing.

Compared to the vaccine developed by Pfizer and the German company BioNTech, the Moderna vaccine may be more likely to cause headaches, sore arms, and related side effects.

Looking at the data from the clinical trials, it also appears that the Moderna vaccine is more effective at preventing serious illness compared to one developed by Pfizer. Of the 30 volunteers that developed severe illness related to COVID-19, everyone received the placebo, not the vaccine.

Dr. Limaye says that could make all the difference in the fight against the pandemic. “We’re worried about severe cases that lead to hospitalization, which leads to death,” she said. “The fact that they were able to prevent any cases of severity — I mean, that’s huge.”

Between the two vaccines, Moderna’s is much easier to ship and store. It doesn’t have to be kept as cold as the Pfizer vaccine, which needs to stay at -70 degrees Celsius. That makes it easier to administer the drug outside of major hospitals.

As Dr. Bloom puts it, “Moderna is the one that I would take out to rural areas and community health centers and private doctors’ offices.”

In July 2020, the federal government signed deals with both companies to acquire 200 million doses in the first quarter 2021. With both vaccines requiring two doses, that would be enough to inoculate 100 million Americans. However, the government just requested another 100 million doses of the Moderna drug by second quarter 2021, which means 150 million people could be vaccinated in just a few months.