On December 2, 2020 the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (“MHRA”) announced approval of Pfizer and BioNTech’s coronavirus vaccine. According to a press release from the U.K. government:
This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a promising medicine or vaccine during a public health emergency in the shortest time possible. This is done as the packages of data become available from ongoing studies on a staggered basis.
Reports indicate that the National Health Service will be ready to begin vaccinations for individuals in high priority groups next week. On November 20, the companies previously announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective. The U.K has ordered 40 million doses of the vaccine, which will provide vaccines for 20 million people. The U.K. government also released two documents:
- Information for Healthcare Professionals on Pfizer/BioNTech COVID-19 Vaccine (link here).
- Information for UK Recipients on Pfizer/BioNTech COVID-19 Vaccine (link here).
This vaccine candidate has an Emergency Use Authorization (“EUA”) application pending with the U.S. Food and Drug Administration (“FDA”) (Health Law Pulse summary here.). The FDA has announced that the Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee will have a meeting on December 20, 2020 to consider the EUA. Materials for the meeting can be found here.
On December 2, 2020 the CDC announced it will be updating its guidelines for individuals that may have been exposed to the coronavirus. Previously, the CDC had recommended a 14-day quarantine following possible exposure. The updated guidelines will recommend a quarantine of seven or ten days, depending on test results and symptoms. For instance, if an individual receives a negative test result, the CDC recommends a seven day quarantine period. If the individual does not develop symptoms, the CDC recommends a ten day quarantine period.
On Tuesday December 1, 2020, the U.S. Centers for Disease Control Advisory Committee on Immunization Practices held an emergency meeting regarding the prioritization of individuals to receive the coronavirus vaccine following EUA approval from the FDA. The Advisory Committee approved a recommendation that:
When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) health care personnel and 2) residents of long-term care facilities.
Long-term care facility residents are defined as “adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.” The CDC Director, Robert R. Redfield subsequently approved the recommendation as the agency’s formal guidance. On November 23, 2020, the State of Texas announced guiding principles for vaccine allocation, which may be found here.
Norton Rose Fulbright attorneys will continue to provide relevant updates on the COVID-19 PHE on the Health Law Pulse.