On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must be monitored for two months after receiving the vaccine and Pfizer anticipates seeking EUA in the third week of November. The Phase III trial enrolled 43,538 patients and Pfizer announced that “no serious safety concerns have been observed.” Pfizer was quick to note that they were not a part of the U.S. government’s Operation Warp Speed. The company further provided that 38,955 of the enrollees have received a second dose of the vaccine candidate.
FDA guidelines released in October require a vaccine to prevent COVID-19 or decrease its severity in at least 50 percent of people who are vaccinated, compared to a control group receiving a placebo. The FDA has also stated that for a COVID-19 vaccine “issuance of an EUA may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or FDA has completed its formal review of the biologics license application.” The FDA may grant an EUA where:
- The chemical, biological, radiological, or nuclear (CBRN) agent referred to in the March 27, 2020 EUA declaration by the Secretary of HHS (SARS-CoV-2) can cause a serious or life-threatening disease or condition.
- Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2.
- The known and potential benefits of the product, when used to diagnose, prevent or treat the identified serious or life-threatening disease or condition, outweigh the known and potential risks of the product.
- There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.
Pfizer did not release detailed data regarding results of the clinical trial, such as the effectiveness on distinct age groups. The results of Pfizer’s clinical study had been eagerly anticipated. In October, Pfizer CEO Albert Bourla released an open letter regarding the development of a COVID-19 vaccine “to ensure public trust and clear up a great deal of confusion.” The press release issued by Pfizer and BioNTech on November 9 stated they anticipate being able to produce up to 1.3 billion doses of the vaccine by the end of 2021. In July, the companies reached an agreement with the US government to provide 100 million doses of their vaccine. The Pfizer clinical trial protocols may be found here.
November 9, 2020 also saw the FDA’s issuance of an EUA for Eli Lilly’s antibody treatment for COVID-19. The EUA will permit adults and children over the age of 12 who are experiencing mild to moderate COVID-19 symptoms to receive the drug. Secretary of the US Department of Health and Human Services Alex Azar tweeted that “[a]uthorization of this new Eli Lilly antibody treatment is a significant step forward in treating patients and bridging us to the rollout of safe and effective vaccines, with all of these efforts made possible by #OperationWarpSpeed.” Additional information from the FDA may be found here.
Norton Rose Fulbright attorneys will continue to provide relevant updates on the COVID-19 PHE on the Health Law Pulse.