A committee of independent experts recommended that the Food and Drug Administration should approve the Moderna COVID-19 vaccine for people 18 and older. This is the second COVID-19 vaccine to go before the committee – the first, made by Pfizer and BioNTech, was approved last week. The organization is expected to issue a license for the Moderna vaccine within a day or two.
“This is a very opportune time for us to move science forward,” said Hayley Gans, a committee member and professor of pediatrics at Stanford University Medical Center, during the committee’s deliberations. The available evidence for the benefits of the vaccine is above all, she said. “That really helps us to be able to move forward with the pandemic, and finally provide a safe and effective way to protect the herd. ”
The FDA review of the vaccine ahead of the meeting confirmed that it is safe and 94 percent effective in preventing a typical COVID-19, all but promising a vote of confidence. The Advisory Committee on Vaccines and Related Biological Products (VRBPAC), which met to discuss the data, spent the day discussing the additional questions left around the vaccine and how Moderna should vaccines were administered in the placebo group of her clinical trial.
To test how well the vaccine works, during the clinical trial some people received a placebo, or an inactive pill instead of the vaccine. Moderna said during his presentation that the company plans to offer active vaccines to people who received the placebo promptly. Pfizer and BioNTech, on the other hand, plan to wait for participants in the placebo group to qualify under their vaccine priority plans before telling them about their placebo status. Moderna would vaccinate this group with doses scheduled for the clinical trial, which the company argues means study participants are not cutting line.
Telling the placebo group that they received, of course, receiving a placebo limits the ability of the vaccine study. If there are people know they have not been vaccinated, their behavior may change, and once vaccinated, researchers will no longer have control over the vaccine group. That worries the VRBPAC, which would like to collect data as long as possible. The pharmaceutical companies, however, said they believe it is their duty to offer vaccines to the placebo group.
The committee also raised a handful of issues that have not yet been addressed by the clinical trials. Moderna does not yet know, for example, whether the vaccine can protect against asymptomatic cases of COVID-19 – stop infection with the coronavirus completely – or if it simply prevents symptoms. Early data from Moderna suggest that it may prevent asymptomatic infection. Test participants who had no symptoms were tested for the coronavirus between the first and second dose. People who were vaccinated were less likely to test positive than those in the placebo group. More answers to that question come in January, Moderna said.
Moderna is still analyzing data collected after the vaccine was submitted for approval. An additional 450 cases of infection were reported in the lawsuit following that claim, which will increase understanding of the effectiveness of the vaccine.
With this vaccine and the Pfizer and BioNTech vaccines being distributed nationwide, the pharmaceutical companies and federal agencies are monitoring how well they are working and how safe they are. as they are in the real world. Already, regulators are finding effects not seen in clinical trials – a handful of allergic reactions and cases of anaphylaxis have been reported in the US and UK in people who have received the Pfizer and BioNTech vaccine , for instance. The FDA is investigating U.S. incidents.