In the span of a week, the FDA has issued emergency authorizations for both the Pfizer/BioNTech and Moderna vaccines. Here are some key questions and answers about the historic US vaccine program:
Both Pfizer/BioNTech and Moderna vaccines are mRNA vaccines that are injected into the upper arm muscle. They represent a new form of vaccine technology: using messenger RNA, they instruct our cells to make a protein that triggers an immune response.
The mRNA vaccines give instructions to our cells to make and display “spike proteins”, which are found on the surface of the Sars-CoV-2 virus. When our immune system realizes this protein does not belong, it begins producing antibodies. Through this process, it learns how to respond to future exposure to the virus.
In order to be effective, two doses are required. For Pfizer, the second dose is 21 days after the first, and for Moderna, 28. In clinical trials, the vaccines were found to offer protection against Covid-19, but it is still unknown how long that protection lasts. Importantly, those protections don’t kick in until about a week after the second dose. Only people with a history of severe allergic reactions have been discouraged from getting the vaccines.
Though both vaccines prevent 95% of Covid-19 cases, vaccinated individuals may still be contagious and spread the virus to others. It will be important to maintain precautionary measures before and after getting vaccinated.
Though only the Pfizer/BioNTech and Moderna vaccines have received emergency authorizations in the US so far, there are many other manufacturers working to bring vaccinations to market.
According to data compiled by London School of Hygiene and Tropical Medicine Vaccine Center, over 200 vaccines are in various stages of development and testing worldwide, with 12 in the last stage of clinical trials. Other notable manufacturers with contracts with the US include Janssen Pharmaceutical Companies, University of Oxford/AstraZeneca, Novavax and Sanofi/GSK.
Plans for vaccine distribution will vary by state, though the Centers for Disease Control and Prevention (CDC) and related advisory group recommendations guide their development. So far, state allocation plans have focused on the earliest groups prioritized by the CDC’s advisory committee. For the first phase, the committee prioritized healthcare workers and those in long-term care facilities.
Of course, the larger challenge will be to distribute the vaccines effectively. The Surgo Foundation’s vaccine allocation planner estimates the number of individuals in each group, and taken together with the reported initial supply, hints at an uncomfortable reality: it is quite likely that the initial distributions of the vaccine will be insufficient for even the highest-priority groups before spring.
Logistics further complicate the rollout. Though the incoming Biden-Harris administration hopes to invest $25bn into manufacturing and distribution, the Guardian reported that local health departments are finding themselves underfunded and understaffed.
Advisory groups have recommended the consideration of statistical tools, such as CDC’s Social Vulnerability Index (SVI) or Surgo Foundation’s Covid-19 Community Vulnerability Index (CCVI), to make equitable allocations of any Covid-19 vaccine. Researchers studying the relationship between these indexes and Covid-19 hotspots have found that the counties with high vulnerability, especially those with higher proportions of minorities, were hit the hardest by the pandemic. The CDC’s Morbidity and Mortality Weekly Report in June had similar findings.
Other researchers worry about the legal implications of making allocation decisions based on race. Instead, they propose the use of Area Deprivation Index (ADI) to sidestep potential legal challenges. However, the use of ADI to make allocations, according to their analysis, would yield lower benefits to minority communities, as compared to the SVI.
On a long enough timeline, quite probably. As noted earlier, the initial shipments of the Pfizer vaccine are not enough for most states to cover even the most high-priority groups. Leaders of Operation Warp Speed (OWS) hope to make 20m doses available before the end of the year, with another 60m in January and 100m in February.
The US has also secured over 2bn doses across several agreements with manufacturers. While this number may seem high, it is important to consider the time it takes for each vaccine to go through manufacturing, authorization and distribution.
Though the US has secured 100m doses of the Pfizer/BioNTech vaccine, with 500m more doses optioned, it is unlikely states would see even the first 100m until next year. Pfizer has already had to downsize their expected 2020 global production by 50m doses due to supply chain issues.
The Moderna vaccine also provides additional supply: almost 6m doses were shipped when the FDA authorized the vaccine on Friday. The US Department of Health and Human Services (HHS) has secured 100m additional doses of the Moderna vaccine, with the expectation of continuous delivery through June 2021.
The Guardian reported earlier this week that while employers have the right to mandate vaccines and some – such as hospitals – have done so in the past, the Covid-19 vaccine is complicated because it is still technically considered experimental until it is granted full approval. Reporter Lauren Aratani notes, “For now, the rights of employers to mandate a Covid-19 vaccine will be in a legal gray area for the indefinite future.”
Depending on who you are, it is quite possible that there are millions ahead of you in the vaccine line. The New York Times created a tool for estimating your approximate place, but it is important to know there are many unknowns that make assigning an estimated time to correspond to your place quite difficult.
Many states are still figuring out exactly who counts as an essential worker. The questions will be resolved on a state by state level, and are further complicated by the rollout and availability of the vaccine supply.
Normalcy will take some time to arrive. Dr Anthony Fauci, at an online event at Harvard TH Chan School of Public Health, noted that if vaccine administration goes well, some form of normalcy might be within reach by the end of 2021.
There are two important moments that vaccines make possible, according to an analysis by McKinsey & Company. One is an epidemiological endpoint: when enough of the population has immunity to the virus that community transmission becomes less likely. How quickly this arrives depends largely on the success of distributing and administering the vaccines. Expert estimates put this level of immunity as achievable by the third quarter of 2021, unexpected complications withstanding.
The McKinsey analysis notes that the restoration of parts of our social or economic lives, the second endpoint, may arrive sooner than the epidemiological end of the pandemic.