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In the last month, there has been promising news on the COVID‑19 front. Several vaccines have demonstrated high efficacy in preventing serious infection with the virus. In this edition of Independence Edge, we focus on BNT162b2, the vaccine that is likely to receive the first Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the prevention of COVID‑19.
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Background
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On November 18, 2020, drug manufacturers Pfizer and BioNTech announced that their collaborative vaccine BNT162b2 was more than 95 percent effective in preventing COVID‑19, based on Phase 3 trial data.
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Given as a two‑dose regimen, administered three weeks apart, BNT162b2 is a messenger RNA (mRNA)‑based vaccine. Most traditional vaccines contain a small amount of virus, which triggers the immune system to produce antibodies to it. BNT162b2 contains no virus; instead, it gives cells the genetic “recipe” for the characteristic spike proteins that are found on the surface of the coronavirus. As the body begins producing these proteins, the immune system is triggered, thereby creating the defense mechanism that should help protect the person from serious infection if they are exposed to the virus.
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Clinical trials
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The Phase 3 trial began in July 2020, with nearly 44,000 participants from six countries, randomized across age, race, and ethnicity. Half of the participants received the vaccine, while the other half received a placebo. At this time, there have been 170 confirmed cases of COVID‑19 among all participants, with only 8 cases in those who received the vaccine. No serious adverse effects from the vaccine were reported.
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Based on these results, Pfizer and BioNTech requested an EUA from the FDA on November 20, 2020. The FDA’s decision is expected in the next few weeks. It is important to remember that an EUA is not the same as an FDA approval. An EUA grants temporary access to an investigational product that may be useful in preventing or treating a life‑threatening disease when no FDA‑approved alternatives are available.
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New participants are still being enrolled in the Phase 3 trial, and the trial will continue even if the EUA is granted. All participants will be followed for two years to assess long‑term safety and efficacy.
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Access
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If the EUA is granted, it will identify the criteria to determine the most appropriate candidates to receive the vaccine. In addition, Pfizer will launch a pilot program in New Mexico, Rhode Island, Tennessee, and Texas that will help refine future plans for larger‑scale national and international vaccine distribution. These states were chosen based on their variance in size, population, health care infrastructure, and delivery capabilities in both rural and urban areas.
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Challenges
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There are several concerns about BNT162b2, including:
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- Production capabilities. Manufacturers anticipate global production of as many as 1.3 billion doses in 2021. That number sounds high, but it must be halved when determining how many people can receive it since each vaccine requires two doses.
- Cold‑chain storage requirements. The vaccine must be stored at ‑80oC, which may create challenges. Although manufacturing facilities and research hospitals have freezers that can maintain this temperature, most doctors’ offices and pharmacies do not. By comparison, the flu vaccine only needs to be stored at 2‑8oC. Pfizer has developed customized packaging to meet these cold‑chain storage requirements, but this creates an added expense to the manufacturing chain. In addition, there are limits to how long this packaging can be effective; the vaccine destabilizes quickly once it begins to thaw.
- Compliance. The two‑dose regimen raises concerns for individuals who may not follow up with their provider to receive the second dose. Noncompliance with the regimen may reduce the vaccine’s protective effect.
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Independence is committed to tracking the development and approval of COVID‑19 therapeutics and vaccines through the FDA pipeline and how their availability may impact our members. In an upcoming edition of Independence Edge, we will discuss the second vaccine likely to receive an EUA from the FDA, Moderna’s mRNA‑1273.
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