On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate. Earlier this week, the companies announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective. In addition to the effectiveness, there were no serious side effects among the 41,135 participants. Limited participants had side effects, such as 3.8% had fatigue and 2% had headaches. According to the press release issued by the companies, the efficacy was consistent across age, gender, race, and ethnicity demographics. The companies announced that approximately 42% of global participants have racially and ethnically diverse backgrounds. Even amongst participants aged 65 and older the efficacy was over 4%.
In October 20, 2020 guidance, the he FDA provided they may issue an Emergency Use Authorization once the FDA determines certain statutory requirements have been met:
- 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.
Additionally, for COVID-19, an assessment will be made considering “the target population, the characteristics of the product, the preclinical and human clinical study data on the product, and the totality of the available scientific evidence relevant to the product.” Earlier in the week, Moderna announced their COVID-19 vaccine candidate, which was co-developed by the U.S. National Institute of Allergy and Infectious Diseases, demonstrated 94.5% effectiveness. Moderna stated they would submit an Emergency Use Authorization “in the coming weeks.”
The U.S. Centers for Disease Control and Prevention (“CDC”) recommended against traveling for Thanksgiving in an Advisory released on November 19. Noting that there have been more than 1 million new cases of COVID-19 reported in the past week, the CDC advised that “the safest way to celebrate Thanksgiving is to celebrate at home with the people you live with.” The CDC states that “[t]ravel may increase your chance of getting and spreading COVID-19” and “[p]ostponing travel and staying home is the best way to protect yourself and others this year.” The Advisory provides the following recommendations if individuals choose to travel:
- Check travel restrictions before you go.
- Get your flu shot before you travel.
- Always wear a mask in public settings, when using public transportation, and when around people who you don’t live with.
- Stay at least 6 feet apart from anyone who does not live with you.
- Wash your hands often or use hand sanitizer.
- Avoid touching your mask, eyes, nose, and mouth.
- Bring extra supplies, such as masks and hand sanitizer.
- Know when to delay your travel.
The CDC also states that attending a virtual Thanksgiving is the safest choice this year and if you do attend a Thanksgiving gathering you should bring your own food and drink.
Norton Rose Fulbright attorneys wish you a Happy and safe Thanksgiving. We will continue to provide relevant updates on the COVID-19 PHE on the Health Law Pulse.