Question: It’s likely Pfizer gets the Emergency Use permission, but what does that mean for your average American? Who would get the vaccine under the Emergency Use designation? And what about vaccines for children?
Answer: From what I’m reading, including this helpful overview from the NY Times, if everything goes as well as possible (that’s a big if), the vaccine could be authorized for use among certain high risk populations by the end of the year. Pfizer and its partner, BioNtech, expect to have 30-40 million doses available by the end of the year, and to further ramp up to 1.3 billion doses/year (note: as described in Nature, full vaccination= 2 doses with 2nd dose given 3 weeks after 1st). Clearly, it will take some time for the whole population to be vaccinated.
Which populations are prioritized for initial vaccine distribution?: A few days ago (11/5), CDC issued the COVID-19 Vaccination Program Operational Guidance to help each state, local, territorial, and Tribal government “plan and operationalize a vaccination response.” Included in the Guidance is each state’s draft executive summary, which describes (among other things) the populations that will be prioritized in the initial vaccine distribution. For New York, “prioritization of population groups will be based on risk, maintenance of essential services, and community prevalence of COVID-19…. more than 800,000 critical health care workers in hospitals, long term care facilities (LTCFs), emergency medical services, and home care and approximately 83,000 LTCF residents will be targeted during the initial phase of limited vaccine supply. As more vaccine becomes available, other frontline essential workers, medically high risk individuals, and individuals over 65 will be targeted.” You can check out your state’s draft plan executive summary here.
What about children?: Pfizer trial participants originally included those ages 18+, who are not pregnant, in good general health and have not been previously diagnosed with COVID-19. In October, Pfizer received FDA approval to expand enrollment to include those ages 12-17. You can read more about the trial’s plans from clinicaltrials.gov, here. Generally, trials start with healthy adults and as safety is proven, they work their way to younger and younger populations, from teenagers down to young children. This process allows vaccine developers to adjust dose to minimize side effects and maximize immune response. While the inclusion of children ages 12-17 is fantastic news, data on vaccine safety and effectiveness for younger children is still missing. A vaccine for younger children will still be some time in coming– some experts estimate Fall 2021. Meanwhile, because pregnant and breastfeeding women have been excluded from this trial (and the preponderance of others), we will have to rely on the safety/efficacy evidence stemming from those who become pregnant while enrolled in the trial(s). A good run-down of the issues of vaccines and pregnancy is offered by Johns Hopkins experts, “Will Coronavirus Vaccines Be Safe for Pregnant Women?”
How were priority populations determined?: CDC is making COVID-19 vaccination recommendations based on input from the Advisory Committee on Immunization Practices (ACIP), a federal advisory committee of medical and public health experts. In the context of limited vaccine supply, ACIP offers these four goals for prioritizing distribution:
- Decrease death and serious disease as much as possible
- Preserve functioning of society
- Reduce the extra burden the disease is having on people already facing disparities
- Increase the chance for everyone to enjoy health and well-being
Based on these four goals, ACIP suggests that four groups be initially prioritized: Healthcare personnel; Workers in essential and critical industries; People at high risk for severe COVID-19 illness due to underlying medical conditions; and People 65 years and older.
Finally, several other groups have issued vaccine prioritization recommendations, which informed ACIP’s recommendations, including:
- Johns Hopkins Bloomberg School of Public Health: Interim Framework for COVID-19 Vaccine Allocation and Distribution in the United State
- The National Academies of Sciences, Engineering, and Medicine: Framework for Equitable Allocation of COVID-19 Vaccine
- WHO Strategic Advisory Group of Experts (SAGE): WHO SAGE Values Framework for the Allocation and Prioritization of COVID-19 Vaccination
- WHO SAGE: WHO SAGE Roadmap for Prioritizing Uses of COVID-19 Vaccines in the Context of Limited Supply