The looming question is: when will the public be able to start getting the vaccines?
As reported yesterday, Pfizer and BioNTech completed their Phase III trial of their COVID-19 vaccine, which demonstrated 95% efficacy. They plan to submit for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) “within days” with some sources suggesting Friday, November 20. Moderna has also reported successful interim data on their Phase III trial, with more expected soon. The FDA has a vaccines advisory committee meeting scheduled for December 8, 9 and 10, with some sources expecting EUAs for both vaccines potentially being approved on December 10.
With all those expectations for available vaccines, the looming question is: when will the public be able to start getting the vaccines?
Not immediately after an EUA, although potentially by the end of the year.
“We are covering new territory,” said Norman Baylor, president and chief executive of Biologics Consulting and former director of the FDA’s Office of Vaccine Research and Review.
The timeline might depend on the responses of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). These committee members are not employed by the FDA, but are independent experts in that area. They may have follow-up questions or, for that matter, have issues with the details of the data presented. Their job is to review the evidence and make a recommendation to the FDA via a vote. Then the FDA considers if they will accept the recommendations and issue an EUA.
Assuming that happens quickly, an advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will make recommendations on prioritizing vaccine dosing. The Advisory Committee on Immunization Practices (ACIP) has a preliminary meeting scheduled on Monday, November 23, but does not plan on voting on that date. The CDC will consider ACIP’s recommendations.
The general consensus has been that people first to receive the vaccine will likely be physicians and nurses on the front lines of treating patients. After that, people at high risk for COVID-19, such as the elderly and people with specific health problems, will be in line.
Generally, it’s unlikely the vaccine will be available to the general public until the spring or summer of 2021. At least one timeline suggests March-April 2021.
Some of the limitations are related to manufacturing. According to Alex Azar, secretary of Health and Human Services, the U.S. will have about 40 million doses of the two vaccines by the end of the year, which would be enough for about 20 million people—both vaccines require two doses about 28 days apart.
“We now have two safe and highly effective vaccines that could be authorized by the FDA and ready to distribute within weeks,” Azar said on a briefing on Operation Warp Speed yesterday.
After that initial manufacturing supply, the companies should be able to make about 40 million doses per month for Americans. It’s worth keeping in mind that the Pfizer-BioNTech group has European and other manufacturing obligations, as does the Moderna group via contracts with other manufacturers. BioNTech is a German company.
Operation Warp Speed officials indicate that states and territories are prepared to begin distributing the vaccines within 24 hours of receiving regulatory authority.
It is possible there will be at least two more vaccines available in the coming weeks and months. One is by AstraZeneca and the University of Oxford. That group published positive Phase II data today and suggests they will have available data on their Phase III trial by Christmas. Johnson & Johnson has a vaccine in trials now with expectations of actionable data by the end of the first quarter of 2021. One positive aspect of the J&J vaccine is that it only requires a single dose.
One possible key to distributing the vaccines to older Americans quickly is a deal the U.S. government entered into with Walgreens and CVS. Azar also indicated they have formed more agreements with pharmacy chains and independent pharmacies.
“We have seen tremendous uptake of that option already,” Azar stated yesterday. “Nine-nine percent of skilled nursing facilities across the country have signed up, and 100% of facilities in 20 states are signed up.”
Both of these vaccine candidates require two doses about 28 days apart. The Pfizer-BioNTech vaccine requires storage at about -94 degrees F, which requires specialized freezers. The Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F.
The ultra-cold storage needed for the Pfizer-BioNTech product is not unprecedented. Debra Kristensen, who has worked in vaccine innovation and supply chains at PATH, an international public health nonprofit, for thirty years, told NPR, “I believe it can be done. Ebola vaccine, for example, was successfully used in a few African countries and also required this ultra-cold chain storage.”
Distributing the vaccine under ultra-cold chain storage conditions, she said, “is possible, but it’s definitely going to be much more expensive and more difficult.”
Pfizer has designed its own packaging using dry ice that can be stored for weeks without the specialized freezers. Moderna’s vaccine requires more typical storage.
Pfizer launched a pilot program in four U.S. states to deliver the vaccine. The states are Rhode Island, Texas, New Mexico and Tennessee. They were chosen based on overall size, population diversity, immunization infrastructure, and a combination of urban and rural settings.
“We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” Pfizer stated earlier this week.
Pfizer indicated the four states won’t get the vaccine earlier than other states because of the pilot program.
Pfizer and BioNTech have a $1.95 billion agreement with the U.S. government to supply 100 million doses of the vaccine, with an option for another 500 million. The companies accepted no development funding from the U.S. government. The Moderna vaccine trials were developed with financial and logistical support from the U.S. National institute of Allergy and Infectious Diseases (NIAID) and Operation Warp Speed and could receive up to $2.45 billion in federal government funding. Health and Human Services (HHS) originally granted Moderna $955 million for clinical development. They also have a $1.5 billion deal to supply 100 million doses to the U.S. government.
In August, Operation Warp Speed selected McKesson Corp. to help distribute the vaccines. The company already had a vaccine distribution contract with the U.S. government starting in 2017. It has had similar contracts earlier, such as for the distribution of the H1N1 vaccine during the 2009-2010 pandemic. McKesson is the largest distributor of seasonal flu vaccines in the U.S.
