The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration recommended that the agency give approval to Phizer to start distributing their coronavirus vaccine throughout the United States. The FDA could decide as early as Friday to give the go-ahead on vaccine distribution, ending a remarkable process that brought a vital vaccine from concept to market in about 8 months.
It’s a process that usually takes 3-5 years. But with billions of dollars from the government being poured into vaccine development at several different companies, the odds were pretty good that there would be a quick breakthrough.
Trials are ongoing and not everyone will be able to get a shot. The agency is expected to approve use for those over 16 and women who are not pregnant. Testing on those specific groups continues.
It’s unclear whether the FDA will authorize Pfizer and BioNTech’s vaccine for use in certain groups. Some people, including pregnant women and young children, will likely have to wait to get the vaccine in the U.S. until Pfizer can finish trials on those specific groups. The FDA said Tuesday that there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women and people with compromised immune systems. Regulators in Canada, the U.K. and Bahrain have all cleared the vaccine for use by most adults.
The committee recommended emergency authorization of the vaccine for people who are 16 years old and older. Prior to the vote, some experts in the meeting argued to limit its recommendation to people who are at least 18, saying the safety data on 16- and 17-year olds was “thin.”
Pfizer says it will be able to supply 50 million doses by the end of the year. That would inoculate 25 million people since the vaccine requires 2 doses about 3 weeks apart to be fully effective. The government says it would be able to vaccinate any American who wanted one by the end of June. That’s an ambitious goal and some experts doubt that it can be reached.
But Moderna, Inc. also has a vaccine that has proven to be even more safe and effective and is close to being approved. Together, the Pfizer and Moderna vaccines (along with another vaccine from AstraZeneca) could easily supply the hundreds of millions of doses needed to vaccinate everyone.
There are going to be bottlenecks, partly because the cold storage requirements of the Pfizer vaccine are severe.
Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, presenting potential logistical challenges for rural areas and inner cities that may not have good health-care infrastructure. By comparison, Moderna has said its vaccine can be stored for up to six months at minus 4 degrees Fahrenheit.
The FDA’s advisory committee will meet on December 17 to go over the data from the Moderna trials. It’s possible that shortly before or after the New Year, the Moderna vaccine will also be approved for emergency use.
The pandemic wasn’t slowed down much by lockdowns or masks, or social distancing. There will be debates for years on how necessary the lockdowns were, did they need to be that severe, and was there another way.
But politicians and many people put their faith in public health “experts” who proved to be little better than gypsy fortunetellers. There’s got to be a better way to deal with a pandemic involving a contagious disease.
I hope we find it before the next one hits.