Cross-posted from the U.S. Chamber of Commerce
The Food and Drug Administration has granted emergency use authorization (EUA) for COVID-19 vaccines developed by Pfizer and Moderna. These were among the more than 200 vaccine candidates in development in early 2020, and they are expected to be the first of multiple vaccines to become available in the United States in the coming months.
States are now starting to prioritize, allocate, and deliver the first vaccines. Here’s what you need to know about the process, the expected timelines, and what it means for you.
What was the approval process for these vaccines?
The Pfizer and Moderna vaccines received EUA after extensive scientific reviews concluded each vaccine met the highest standards for safety and effectiveness. The vaccines benefited from a production process that enabled broader manufacturing to begin before clinical trials with more than 70,000 subjects concluded. The EUA was not granted until there was certainty that the vaccines developed by both manufacturers met the same safety and efficacy standards as any other vaccine. The FDA determined both vaccines are “highly effective,” and this was confirmed by several states that established their own vaccine review panels.
How many doses of the vaccines are needed to work?
Vaccines developed by Pfizer and Moderna require cold storage and patients must receive two doses administered two or three weeks apart respectively. Additional vaccines with different storage or dose requirements are being developed by AstraZeneca, NovavaxAB, and Johnson & Johnson. These alternative vaccines were in late-stage clinical trials as of mid-December.
How many Americans need to be vaccinated to significantly control the spread of COVID-19?
Experts say we need 70% to 80% of the population – more than 200 million Americans – to have immunity to the novel coronavirus for us to benefit from herd immunity. “With herd immunity, the vast majority of a population are vaccinated, lowering the overall amount of virus able to spread in the whole population,” according to WHO.
How long will it take to vaccinate enough Americans and achieve herd immunity?
There are many estimates that attempt to forecast when the U.S. population will reach the potential herd immunity threshold.
Global management consulting firm Oliver Wyman estimates that could occur as soon as June when you combine rates of natural infection and vaccination. “You would hope that when you get into the second quarter of 2021, April, May, June, that by the time you get to the end of the second quarter into the third quarter of the year, you will have as many people vaccinated as you need to get vaccinated,” Dr. Fauci said in December.
Note: It is unclear how long an individual remains immune to COVID-19 after infection or vaccination.
What are some of the factors that may affect that timeline?
Willingness of the public to receive a vaccination is one of the critical factors in determining how fast the U.S. can reach the herd immunity threshold. A recent survey by Pew Research Center suggests 60% of U.S. adults said they would get vaccinated against COVID-19 if a vaccine were available. But about two in ten “definitely” would not get the shot. The trust gap is largest in the Black community, with only 14% of respondents in a recent survey saying they trust the safety of the vaccine.
Who decides how much vaccine each state gets, and how are those allocations determined?
The U.S. government allocates vaccines to 64 jurisdictions, including all states and territories, based on adult population.
Officials at Operation Warp Speed have said they expect to distribute enough doses to vaccinate more than 30 million people by the end of January 2021.
The Vaccine Allocation Planner allows you to estimate availability based on population and vaccine supply. Operation Warp Speed provides six-week forecasts of potential allocations to the states.
Who’s getting the vaccine first, and what’s the sequence for other groups?
The CDC has recommended that states prioritize front-line healthcare workers (21 million) and long-term-care facility residents (3 million) during the first phase of the vaccine rollout.
The next phase focuses limited vaccine doses on frontline essential workers beyond healthcare (30 million) and people over the age of 75 (21 million). Other essential workers (57 million), people between the ages of 65 and 74 (32 million), and anyone over the age of 16 with high-risk medical conditions (>110 million) will receive vaccinations in a later stage. It’s important to note that there is significant overlap among these groups.
While vaccine distribution is tightly controlled right now, patients are expected to be able to obtain shots at more locations, including pharmacies, when large numbers of doses become available during the second phase of the rollout.
What constitutes an “essential employee” and how are decisions being made about prioritization within that group while supplies remain limited?
The Department of Homeland Security established a list of “essential critical infrastructure workers” in early 2020 that “is intended to be overly inclusive, reflecting the diversity of industries across the United States.” This list was originally used to ensure critical workers had access to their workplaces during broader shutdowns.
The categorizations are now being used to prioritize the distribution of COVID-19 vaccines. Jurisdictions are expected to use DHS/CISA guidelines to prioritize essential workers during Phase 1b, according to the CDC’s COVID-19 Vaccination Playbook. “Critical infrastructure workforce varies by jurisdiction,” according to the document, which is intended to inform state and local planning processes. “Each jurisdiction must decide which groups to focus on when vaccine supply is limited by determining key sectors that may be within their populations (e.g., port-related workers in coastal jurisdictions).”
When will doses become available to the general public?
The goal is for every American who wants a vaccine to be able to get one by the end of June 2021, according to the U.S. Department of Health and Human Services.
The U.S. government has contracted for 900 million doses of vaccine. Based on their experience vaccinating millions of people against seasonal flu each year, experts expect the vaccination process to go relatively efficiently once additional vaccines are approved and become available to jurisdictions across the country.
Can we stop wearing masks and practicing social distancing now that vaccines are available?
No. It is essential that all of us continue to wear face coverings, maintain physical distance whenever possible, and follow the guidance of local public health officials. “I don’t believe we’re going to be able to throw the masks away and forget about physical separation and congregant settings for a while, probably likely until we get into the late fall and early next winter,” Dr. Fauci said. (CSIS)
Face coverings reduce the risk to the wearer and to those they come in contact with by reducing the risk that droplets containing the novel coronavirus will pass from one person to another. (Mayo)
Face masks are not a substitute for social distancing. CDC recommends staying at least six feet away from anyone who is not in your household. (CDC)
Health experts also recommend getting vaccinated against seasonal influenza, another deadly respiratory illness that claimed 34,000 lives during the 2019-2020 flu season.
Where can I find more information and stay up to date?
One of the most challenging things for any business owner right now is identifying the most reliable and relevant information about the state of the pandemic. These are some trusted resources you will find helpful as you may find helpful:
- Interactive Map of COVID-19 Clinical Trials in the U.S. (U.S. Chamber)
- COVID-19 Dashboard (CSSE)
- What You Need to Know about COVID-19 Vaccines (CDC)
- Common Vaccine Side Effects (FDA)
- Vaccine Development Tracker (Bloomberg)
- Operation Warp Speed Infographic on Distribution Process (HHS)
- Vaccine Development 101 (FDA)