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Like everyone else, I was thrilled by Pfizer and BioNTech’s joint announcement of a COVID-19 vaccine that is 90% effective. That made me wonder what exactly is involved in developing and—most importantly—proving that a vaccine works and is reasonably safe. The Pfizer/BioNTech vaccine is in Phase III trials. What does that mean?

The Food and Drug Administration’s process for new drugs normally is complex and lengthy. It can easily stretch out for years and create reams of data. But the FDA can shorten that time when the need is especially great, which certainly is the case with COVID-19 vaccines.

There are several stages to vaccine development which involve exploratory research, multiple rounds of pre-clinical and clinical review, tracking side effects, manufacturing, and quality control. Clinical development has three phases:

Phase I: Small groups take the vaccine to test for safety, efficacy, and to determine the correct dosage.

Phase II: Hundreds of people with different characteristics (such as age and health status) take the vaccine to further understand how it works and whether it is safe.

Phase III: Thousands of people are given the vaccine.

All three phases are tightly controlled and monitored. The FDA reviews the results and may require additional testing or tracking of participants before it approves the vaccine for widespread use. Under various fast-track rules and other programs, the FDA can—and has—changed some of the three phase requirements, including how many people must participate and how long the trials last.

Pfizer and BioNTech will ask the FDA for emergency authorization later this month with just two months of data. The FDA has the authority to allow unapproved medical products to be used in an emergency when there are no adequate or approved alternatives.

As a citizen, I want an effective vaccine as quickly as possible. As a lawyer, I wonder what litigation will inevitably follow with claims that approvals were rushed or wrong. What if vaccines are made mandatory, as the New York Bar Association recommended just last week? Should drug manufacturers receive protections from suit to encourage COVID-19 vaccine development? Like everything this year, so much remains unknown.

Healthcare law.

RDM’s Healthcare Law team works with medical practices and professionals to develop risk management strategies.

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