Don’t let bureaucracy constrict the supply of Covid-19 vaccines – STAT

Vaccination, particularly for the most vulnerable Americans, is the surest way for us to overcome the Covid-19 crisis. As physicians, we celebrate the light at the end of the tunnel, in large part due to Operation Warp Speed. But as members of Congress, we are becoming increasingly concerned that federal bureaucracy continues to stand in the way of rapid, widespread administration of Covid-19 vaccines.

The nation has gained a tremendous amount of knowledge about Covid-19 over the past year. Similarly, over the past few weeks, the scientific community has published encouraging analyses about the vaccines that are playing a starring role in leading us out of this crisis. Mountains of real-world evidence are showing that the two mRNA vaccines authorized by the FDA the first made by Pfizer and BioNTech, the other by Moderna, both of which are supposed to be administered as a two-dose regimen will provide substantial protection against Covid-19 even after only one dose.

Considering that nearly every state is facing shortfalls in the supply of Covid-19 vaccines, we believe this groundbreaking development can help remedy some of the vaccine supply issues the nation is facing. This new evidence indicates that the second doses currently administered to comply with the Food and Drug Administrations emergency use authorizations (EUA) could instead be used as initial first doses essentially doubling the supply.

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Unfortunately, governors who would like to follow this new evidence and provide protection for more citizens have their hands tied by the emergency use authorizations. The FDAs failure to revise it to allow single doses now with second doses administered when they become available may result in tens of thousands of additional deaths. According to recent data coming out of the United Kingdom, it is clear that second doses can be administered up to 12 weeks after the first dose, while maintaining efficacy.

On March 2, President Joe Biden announced the United States will have enough doses of Covid-19 vaccines to allow every citizen to get vaccinated by May 31 under the current emergency use authorizations. Imagine if they were revised to increase the window for administering the second dose. Under this scenario, April 15 could be National Vax Day the day when every vulnerable or essential worker has gotten at least one dose of a Covid-19 vaccine instead of National Tax Day.

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As physicians who are also members of Congress, we are calling on the FDA to break down the bureaucracy and consider revising the EUAs. This call for revising the dosing schedule is bicameral and bipartisan, with seven members of the GOP Doctors Caucus joining two Democratic senators calling for such a change.

What is stopping this from happening? The bureaucracys failure to truly follow the science. The FDA claims the manufacturers themselves must apply for any change to their emergency use authorizations. But we know the FDA has been unwilling to look at real-world evidence in the past, especially if it comes from other countries.

Nonetheless, in this case the Health and Human Services (HHS) secretary has clear statutory authority to revise the EUAs using real-world experience and not wait for a manufacturers request if he or she finds the revision is appropriate to protect the public health or safety.

The large amount of real-world evidence collected from data analysis of the Covid-19 vaccines in Israel and Great Britain two countries whose scientific rigor is well appreciated clearly supports the revision we suggest.

Frustratingly, when Dr. Anthony Fauci was asked this week about changing the EUA, he noted it would be a messaging challenge.

With all the recent calls for patient-centered care, we should be willing to be honest with our patients and give them the choice to receive one dose now, with the knowledge that their designated second dose would be going to a vulnerable or essential person. They can receive a second dose later, and have nearly the same protection.

Calling it a messaging challenge is not following the science. Fauci also raised concerns that offering only a single dose of these Covid-19 vaccines would enable variants to spread. Yet a February report by the Center for Infectious Disease Research and Policy at the University of Minnesota reiterates our calls, and urges timely consideration of these new studies. That report actually came to the opposite conclusion of Fauci: the change needs to be made now in order to get ahead of the variants and potentially save up to 50,000 lives.

The Biden administration must cut through the red tape and ivory-tower arguments now and immediately consider revising the dosing schedule of the Pfizer and Moderna mRNA vaccines to allow for an extended second dosing interval. Any other action will cost lives that need not be lost.

U.S. Rep. Andy Harris (R-Md.) is an anesthesiologist and former head of obstetric anesthesiology at Johns Hopkins University. U.S. Rep. Greg Murphy (R-N.C.) is a urological surgeon who has practiced for more than 30 years. U.S. Rep. Mariannette Miller-Meeks (R-Iowa) is an ophthalmologist and former president of the Iowa Medical Society.

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Don't let bureaucracy constrict the supply of Covid-19 vaccines - STAT