What’s the Holdup?

Operation Warp Speed was wildly successful and a great deal of credit should be given to everyone who contributed to the development of multiple SARS-CoV2 vaccines in record time. This could never have happened without a president experienced in the workings of the business world who could harness the resources of the private sector and federal government in an alliance to benefit the American people. We owe a debt of gratitude to the scientists and researchers who worked 24/7 using the latest in technology to develop these vaccines in record time. Although the federal government was investing heavily in the push for a vaccine, private citizens were donating money to the effort and volunteers stepped up for the critical phase 3 human trials. In the meantime the President was invoking the Defense Authorization Act to convert domestic industries into making essential equipment such as ventilators and personal protective equipment (PPE). He mobilized two Navy hospital ships to assist with overflow COVID-19 patients on each coast. The ultimate victory over the virus, however, could only be expected when there was a safe, effective vaccine. We now have two vaccines that phase 3 trials have shown to be 95% effective. The two vaccines are manufactured by Pfizer & BioNTech and Moderna. The Pfizer vaccine was granted an Emergency Use Authorization (EUA) in the United Kingdom (UK) last week and the Brits began administering the vaccine today. The Pfizer vaccine data will not be reviewed in the U.S. by the Food and Drug Administration (FDA) until Thursday of this week. If the FDA grants Pfizer the expected EUA, then distribution will be begin immediately. The FDA will then examine the the phase 3 study data for the Moderna vaccine the following week, Dec 17. If granted an EUA the Moderna vaccine will be distributed in a similar manner as the Pfizer vaccine. One advantage of the Moderna vaccine is that it does not require the extremely low temperatures (-90F) as the Pfizer vaccine. This may make the Moderna vaccine more suitable for rural areas or inner city clinics.

While we are applauding the researchers and pharmaceutical companies for their diligence and hard work, where is the FDA? Why couldn’t they have met last week as they did in the U.K. and grant the EUA for the vaccine a week earlier? How many lives could have been saved by approving the vaccine one week sooner? The data was obviously available since they examined it in the U.K. and approved the Pfizer vaccine. During his campaign Joe Biden seemed to focus on how many deaths there were every month, week and day that he could blame on President Trump. So how many deaths are we going to blame on the FDA for dragging their feet for a week? President Trump had Thermador producing the special freezers and the military is standing by to transport the vaccine. We are simply waiting for the approval from the FDA. This is not supposed to be political but is there a political reason for waiting a week to look at some data? I’m sure there are a ton of frontline doctors, nurses, EMS personnel and police who are tired of risking their lives against an invisible enemy. Let’s get the vaccine into the arms of those who need it

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