The FDA’s advisory committee has voted to approve an emergency use authorization for the Pfizer-Biontech COVID-19 vaccine for kids, ages 16+ and adults. This gives the go ahead for the manufacturer to distribute the vaccine should the FDA as a whole agree which they have not ignored in the past. The CDC Advisory Committee on Immunization Practices or ACIP committee previously voted last week to prioritize healthcare workers, long term staff and residents to receive the vaccine.

Public testimony was heard, discussion on two topics were completed over the course of the long day from 9-6pm. Discussions were short as commenters were allowed two minutes. Dr. Gruber from Pfizer gave a presentation on the efficacy and safety. The efficacy was touted as 95% and approval was based on two endpoints; participants having at least one symptom plus a central lab positive PCR test.

The data presented only included trial data analyzed up until November 14 and had glaring omissions. For example, there were ZERO black participants in the vaccine group and only three Hispanic. How is that sufficient data on a demographic that has reportedly been disproportionately affected by COVID-19? Will Governor Brown’s Vaccine Workgroup approve the vaccine in spite of these gaps as she has said she will prioritize solving COVID-19 inequities? Oregon’s vaccination plan includes fighting for, “populations disproportionately impacted by COVID-19 and with historic disparities in vaccination rates, including seasonal influenza, will need specific interventions to ensure access to COVID-19 vaccine in culturally appropriate settings.

These populations include, but are not limited to:

• Black and African American communities
• Latino, Latina and Latinx populations
• Migrant and seasonal farm workers and other agricultural and food processing workers

Some side effects reported are appendicitis, Bell’s Palsy and severe anaphylaxis. 60 days of following trial participants seemed insufficient to many commenters and a few panel members. However, there was also concern that millions of people would not get the vaccine if there was a perception of harm as was announced with two healthcare workers experiencing a severe reaction. Had they not had an epi pen they could have died. Dr. Paul Offit suggested a study to follow up with individuals who have peanut and egg allergies but was dismissed since egg protein is not an issue for this vaccine.

Aside from diversity issues, questions remain on the lack of long term data in minorities and all patients, whether the vaccine will cause an enhanced immune response in elderly patients and how long the vaccine works. There is a concern in pregnant women that due to DNA replication occurring during pregnancy, that the messenger RNA could alter chromosomes. The FDA published its findings including side effects that are so far known in a recent report.


--Nicole DeGraff

Post Date: 2020-12-10 16:11:32

Last Update: 2020-12-10 16:57:50