FDA is poised to approve an Emergency Use Authorization (EUA) for the much anticipated vaccine against COVID-19 developed by Pfizer/BioNTech following a strong vote of support by the Agency's vaccine advisory committee
FDA is poised to approve an Emergency Use Authorization (EUA) for the much anticipated vaccine against COVID-19 developed by Pfizer/BioNTech following a strong vote of support yesterday by FDA’s vaccine advisory committee. The unprecedented development of this preventive in less than a year, as well as a similar one from Moderna which seeks an EUA next week, is an achievement that warrants applause for industry, regulatory authorities and the biomedical research community. Hopes are high that these and additional vaccines will reduce disease and restore global health and economic recovery in the coming year. However, such success in combatting the pandemic depends on the ability of manufacturers to quickly and efficiently produce and distribute the huge quantities of vaccines demanded by the U.S. government and public health organizations around the world.
Concerns have been raised by difficulties Pfizer has had manufacturing and scaling up production for its novel RNA vaccine technology. Despite high efficacy rates documented in clinical trials, Pfizer quietly disclosed in a November press release that it would produce only 50 million doses this year, instead of the 100 million initially expected. Now, U.S. officials say they expect 6.4 million doses from Pfizer and another 12.5 million doses from Moderna this year if that company also gains an EUA. That will provide shots for only 10 million Americans initially, far less than needed to provide treatment for more than 17 million health care workers and nursing home residents in the top priority vaccination group. State health agencies, which are charged with determining where to send vaccines as they roll out, are struggling to adjust programs downward.
Pfizer officials indicated in press reports that manufacturing delays arose earlier this year as some early vaccine batches failed to meet standards and the company experienced difficulties obtaining raw materials and supplies ranging from sterile water and laboratory equipment to lipids, chemical components and enzymes. While manufacturing and quality control issues were not on the agenda of the FDA vaccine advisory committee, agency staffers said they will continue to engage with Pfizer to ensure product quality over coming months. And to file for a biologics license application (BLA), which FDA expects Pfizer to do in the near future, the agency expects to see additional information on manufacturing facilities beyond what’s submitted in the EUA application.
Looking ahead, Operation Warp Speed (OWS) officials say they expect to receive enough additional vaccine from Pfizer and Moderna to reach the goal of inoculating 100 million Americans by the end of February 2021. Such coverage, though, relies on obtaining additional products from Johnson & Johnson and from Astra Zeneca, which expect to submit final clinical trial data by late January or early February 2021. As these products rely on more common vaccine production technology, they expect to produce large volumes more readily. OWS acknowledges it will need products from these and other firms to supplement its relatively small 100-million dose purchase from Pfizer, which now may be difficult to increase as other governments have ramped up vaccine orders.
At the same time, other countries are experiencing similar reductions in initial vaccine supplies. U.K. officials expected some 10 million doses from Pfizer this year, but now may get only 5 million. The European Union has purchased 200 million doses, but may receive about 20 million from Pfizer/BioNTech manufacturing sites in Belgium and Germany once the Europeans approve the product. Canada’s initial supply from Pfizer is less than a million doses, far below its 75 million purchase.
The smaller volumes of initial U.S. vaccine supplies leave state health agencies with much fewer doses than expected, complicating the development of local plans for allocation and administration. The medical community still smarts from the debacle earlier this year in procuring and distributing sufficient COVID-19 diagnostic tests and personal protective equipment (PPE) needed by health professionals. No one wants a repeated failure with vaccine distribution.
Despite disappointment with reduced vaccine supplies this year, the delay may provide some breathing room to test and adjust the nation’s planned, but untried, system for distributing millions of doses of innovative vaccines. The required sub-zero cold storage for the Pfizer/BioNTech product promises to be challenging, as seen in a recent run on dry ice supplies in many localities. Both the Pfizer and Moderna vaccines, and possibly some later ones, require two shots, which requires accurate documentation and patient tracking to ensure appropriate and timely vaccine resupply for second doses.
Although there is agreement among U.S. federal health officials that initial vaccines should go to “essential” health care workers and to nursing homes, state health agencies have the task of identifying local distribution priorities and ensuring safe transport of vaccines from distribution hubs to local hospitals and health facilities. States also have authority to decide which groups are next in line following vaccination of those top priority populations. Some want vaccines early for police and fire fighters. There’s also a clamor to first treat highly vulnerable individuals, based on age and health status; groups at higher risk due to ethnicity and living conditions; or essential and frontline workers considered more vulnerable due to the nature of their jobs, such as teachers, truck drivers, food workers, and maintenance and cleaning crews. Most Americans won’t be eligible for vaccination until next spring, or later.
Just as important as getting the right number of doses to appropriate patients is for health systems to establish information systems able to track these actions and longer-term outcomes. It’s critical to obtain timely information on adverse events, response differences among patient groups, duration of immunity and other impacts. Manufacturers are expected to monitor patients for two years to learn more about duration of immunity and side effects, while also relying on health system medical record systems to capture broader data on vaccine responses and coronovirus infection numbers.