The FDA could approve two COVID-19 vaccines within a matter of days. However, drug makers have tried to keep expectations in check about how much vaccine they can deliver immediately and over the next few months as they grapple with supply chain and manufacturing challenges.
An FDA advisory committee will meet tomorrow to consider whether to approve Pfizer/BioNTech's COVID-19 vaccine for Emergency Use Authorization (EUA). The same group plans to meet next week to review Moderna's vaccine. Authorization could come within days as the FDA indicated yesterday that side effects for the Pfizer vaccine appeared to be common and presented "no specific safety concerns that would preclude" issuing the EUA.
At the same time, reports in the last few days underscore that vaccines will be in limited supply probably through the first half of 2021. These latest projections reinforce predications made by experts for some time now that mass vaccination may not be possible until at least summer.
The CDC has advised states to conduct vaccination in phases, starting with healthcare workers and long-term care residents. Essential workers, adults with health conditions, and adults over 65 years old will then likely get vaccinated before the rest of the public.
How much vaccine will be available in the U.S. and how soon?
Vaccine supplies will be limited by a number of factors, especially raw materials and the fact that drug makers have committed to sell their inventory not only in the U.S. but all around the world. Pfizer announced in recent days that it will not be able to provide the U.S. with more than the initial U.S. order of 100 million doses until June or July. States have received reduced forecasts for initial vaccination as a result.
When it was still unclear which vaccine candidate(s) would succeed, the U.S. initially invested in six vaccines to secure at least 100 million doses of each. In the summer, Pfizer offered the U.S. to double its order, but the U.S. declined. Since then, other countries bought up Pfizer's remaining supply until summer.
So, where does that leave us? There are two vaccine candidates nearing approval. The U.S. pre-purchased 100 million doses of each. Moderna still says it could deliver its 100 million doses by the end of March. Pfizer says it will not be able to provide more than its 100 million doses until June or July. In total, these 200 million doses can vaccinate 100 million people because each person will need two doses, 3-4 weeks apart.
Initial supplies insufficient for all high-risk individuals
These initial supplies will be insufficient to complete Phase 1 of CDC's recommended vaccination plan, meaning they will not be enough to start vaccinating most healthy adults. The CDC says that the first phase of vaccination for critical and high-risk individuals includes the following categories:
- Phase 1a (healthcare personnel and long-term care residents): approximately 20 million people.
- Phase 1b (other/non-healthcare essential workers who can't socially distance): approximately 60 million people.1
- Phase 1c (adults with high-risk conditions and adults 65+): approximately 153 million people (probably far fewer2).
The reports above suggest that the U.S. may be able to inoculate 50 million people with the Pfizer vaccine between now and June and another 50 million with the Moderna vaccine between now and March. That means covering essential workers and some portion of high-risk/older adults in that time but not starting on the rest of the population until spring or summer. While disappointing to some and far below the rosiest predications of some politicians, this is consistent with what many experts have said all along.
Of course, these timelines can change for better or worse. On one hand, there could be further delays. FDA approval is expected in the coming days but is still not official. Further supply chain and manufacturing delays are possible. Most significantly, this schedule does not even account for the challenges of distribution, which will involve 50 different state plans, deep freeze storage requirements, data tracking and follow-up to ensure second doses are administered on time, personnel and PPE for giving shots, convincing enough Americans to get vaccinated, and more.
On the other hand, it is of course also possible for more vaccine to become available more quickly, especially if additional vaccines prove to be safe and effective. The chief advisor to the U.S. vaccine program said this week, for example, that AstraZeneca and Johnson & Johnson might report clinical trial results in January or February. The companies would then need to submit applications for authorization and obtain approval, a process that has taken just over a month so far for Pfizer and Moderna.
What can employers do today to prepare? Join our webinar to find out.
The phones are ringing off the hook with questions from employers about what to expect, what issues to consider, and what they can do today to help ensure vaccination of their workforces and return to normal sooner rather than later.
To address these many questions, Husch Blackwell is hosting a complimentary webinar next week on December 16th:
The webinar will help you prepare for your vaccination plan by:
- Providing an update on vaccination timelines and distribution plans.
- Addressing the possible role of employers in the process.
- Explaining issues that employers should consider, including EEOC and OSHA concerns.
- Identifying action steps to take immediately to prepare.
Register today to join us!
1 While some CDC reports indicate 80-87 million in this group, CDC diagrams and another CDC report suggest that these larger figures include healthcare workers, so I've subtracted them to reach a total of non-healthcare essential workers.
2 The last category of high-risk and older adults is probably significantly smaller than 153 million people because of overlap between groups (alluded to in other CDC reports). For example, it appears that about 30-50% of essential workers have high-risk medical conditions. Some adults over 65, approximately 3 million people, will get vaccines at the very beginning because they are in long-term care. 39% of adults over 65 have high-risk conditions.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.