Is a Two to Three Week Delay on COVID Vaccine Approval Worth It?

The UK has already approved the Pfizer COVID vaccine. This is ahead of the EU and the USA. Everyone knows the Pfizer COVID vaccine will be approved in each of the jurisdictions. However, the U.S. Food and Drug Administration (FDA) has a meeting planned to discuss Pfizer’s data in depth on 10 December. Dr Scott Gottlieb is on the board of Pfizer and says he thinks the added two weeks to have the meeting is worth it for public confidence.

I think the people who believe in the vaccine already believe it. The meeting is not changing the science and is a minimal difference on transparency. There could be an emergency approval in step with the UK and the hearing could still take place.

What difference will it make?

The two or three week lead will enable 2-20 million front line medical staff and some vulnerable people to get their first injection and accelerate the schedule for them to get both injections and the 95% effective immunity.

The United Kingdom has bought 40 million doses of the Pfizer/BioNTech vaccine—enough for 20 million people—and health secretary Matt Hancock today announced the first 800,000 doses will be available next week. The US is expecting about 5 million doses in its first week of availability.

It the science will not change and there is little impact on opinions then the delay is protecting the most vulnerable is not worth it. The delay will not impact the speed of the long term ramp of vaccine production. Pfizer and the other companies are going full speed to generate as many doses as possible.

The major vaccine trials to date have enrolled tens of thousands of people, but their conclusions about effectiveness are drawn from infections in fewer than 200 of them. The Pfizer vaccine had 43000 people in the clinical trial and 177 had infections. There are early indications that the three leading vaccines may protect people over 65. There is no data yet on how the vaccine fares in children and pregnant women. The US and EU will not have more data in the next couple of weeks about the Pfizer vaccine.

All three leading vaccines have beaten the goals of achieving 50% efficacy and reasonable safety based on the clinical trial data so far. The effectiveness is in the 90-95% ranges for the mRNA vaccines.

China and Russia already had COVID vaccines approved. The China and Russia vaccines were approved before all tests were completed. Some other countries have approved vaccines.

Written by Brian Wang,