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,

28 thoughts on “Is a Two to Three Week Delay on COVID Vaccine Approval Worth It?”

  1. Depends upon whether the vaccine results in a specific autoimmune disorder, one which in females prompts an attack upon the placenta during a pregnancy.

  2. now I see the problem; why do people discount humidity as being a possible factor in the spread of COVID, is the "it couldn't be that" factor so high?

  3. It has been incredibly dry in San Diego County all this week. Normally, I have to be careful about petting the cats in the sunlight because they don't like static electricity. But lately I can't even pet the cats at night or early in the morning without generating a lot of static electricity. I think this has been the dryest week I can remember. In the 20s % relative humidity when it is in the 50s and 40s at night.
    We have Santa Anas usually with a hot dry wind, but there is no wind, it is just very very dry. Currently it is 66 degrees F and 15% relative humidity. If it gets to 80 degrees again we will probably be in single digits for relative humidity…already single digits in the local mountains.
    Not good for my skin either. Scratched my face while I was sleeping and now have a lovely red mark.

  4. I would have given it to them by the million before it was approved, but right now, we need to protect those who are most likely to lose their life (due to underling illnesses and working jobs where there is exposure to many people) and/or fill a hospital bed for weeks.

  5. That is something people would have to do the math on. I don't know about the rest of the country but this is the order in San Diego:
    Note that the nursing home residents are already in the first group.
    With the rate of spread in the US, getting vaccines to working people who have 3 or more major comorbidities makes more sense to me. If you get a lot of those first, then a lot less people will be needing hospitalization, and the pressure will come off the hospital staff.
    Perhaps we could be more selective with the old folks, rather than just getting everyone in the nursing homes. But even if they are not dying when they get it, they probably will need to go to the hospital, taking a bed. Also you would test people first to see if they have already had it. No point in vaccinating those who have already had it. My thinking was to minimize the number of cases that would need hospitalization and/or have a high probability of death.
    The fact is that hospital personnel have the protective gear, and know how to use it. Those with none of the comorbidities that somehow get it will be well again in a week or two. Staff with one or more comorbidities you do give the vaccine to. This has been going on for months. Those hospital workers that did not take the right precautions or were not given the right gear already got it. Those that have not gotten it know what they are doing.

  6. I hope everyone's been keeping up with Derek Lowe on the medical stuff.

    He has some good stuff.

    Specifically, if you take 10 million people and just wave your hand back and forth over their upper arms, in the next two months you would expect to see about 4,000 heart attacks. About 4,000 strokes. Over 9,000 new diagnoses of cancer. And about 14,000 of that ten million will die, out of usual all-causes mortality. No one would notice. That’s how many people die and get sick anyway.

    But if you took those ten million people and gave them a new vaccine instead, there’s a real danger that those heart attacks, cancer diagnoses, and deaths will be attributed to the vaccine. 

  7. Much of the threat is that the extra load on the medical staff means that people aren't getting correct medical care.
    In a lot of places, if a couple of doctors or nurses need to go into isolation for a month with CV19, then there is no longer anyone to cover the third shift in the emergency ward or whatever.
    Some places are apparently seeing increased problems, and even deaths, because people aren't getting proper care for completely unrelated illnesses such as car crashes or cancer.
    Not to mention that infected medical staff can spread the disease to many patients.
    Immune medical staff can easily save more lives than immune elderly.

  8. <200 people getting ill, and self-reporting at that, out of 43,000, is too small to tell anything. I mean, it sounds promising that (almost) none of them were in the vaccinated group, but there are just too many variables in such a small number, and too much possibility that the rest of the 43,000 got the CV, and were too asymptomatic, or just neglectful, to self-report.
    And tinkering with the body's cellular RNA to trick it into making certain anti-bodies is different from any vaccine before, bordering on genetic engineering.
    Finally, the Pfizer vaccine has to be kept at Antarctic temperatures (what company makes those iceboxes? It sounds like a good investment, though probably too late already). I'd be surprised if some people didn't got ineffective doses just because they couldn't be kept cold enough.

  9. If the vaccine is sterilizing… Giving it to 20-30 year olds would end the pandemic. That age group is probably responsible for most of the spread.

  10. Challenge trials would show efficacy, individuals could take the risk of taking it prior to the safety data coming in.

  11. So does this actually result in any more people getting the disease? Or does it just shift the casualty numbers so X more Americans but X less British, no net effect?

  12. Didn't they already prove this by banning the viral tests for months while the rest of the world was using them?

  13. Do you have any reason (experimental or even theory) to suggest this could affect fertility?

    Or just a scary combination of Will Smith movies?

  14. Everyone knows the Pfizer COVID vaccine will be approved in each of the jurisdictions

    …the science will not change and there is little impact on opinions…

    They're a rubber stamp? The meeting is not changing the science, it's the independent scrutiny of the data and conclusions that makes this science.

    What difference could it make, the difference between the harm of 100s of thousands and 10s of millions.

  15. I tried to come up with a pro-swamp argument, couldn't.

    I think most stuff should be on a risk-informed basis, not a regulator checklist.

    Give me the best information available, let me decide if I think it is worth a try.

    The regulatory swamp only needs to be involved if someone is going to force me to use the vaccine. If they're making the choice for me, they better have a good safety assessment checklist.

  16. The delay is very important, actually. How else is the FDA going to remind people that they're the gatekeepers you have to suck up to, and don't forget it?

  17. I was wondering about why. I figure maybe Pfizer had to prepare a comprehensive report. And that the FDA had to digest it. If that wasn't the case why the delay. There is a lot about how the pandemic was handled that tic me off.

    I am one of those who believed that we need to move harder and faster than we did. For instances once the vaccine was proven safe in phase one, if would have been a go with me because COVID was out there in the wild killing people. I don't think we need a super safe vaccine. What we need is a vaccine that significantly reduces the COVID death toll. Think of it has a much bigger phases 2/3. The additional months of wait did not make the vaccine safer, it just resulted in more COVID deaths.

    Of course some will say what if the vaccine wasn't effective. I say yes, we wasted money. But saving money wasn't the goal. The goal was saving lives. The testing data would have come in and we would quickly know whether the vaccine was effective or not. Even if it was 20% effective I think we should still vaccinate people because saving 20% is important enough.

  18. It may be politically sympathetic to give it to young healthy healthcare workers first, but that will cost lives.

  19. If these people can't get together because they need flights or whatever, get them on military planes and get them in a meeting tomorrow. Hand them a pen, and tell them they are not getting out of the room until they sign off, or present one heck of a case for not doing so. If they refuse to come, fire them, and get someone else immediately who will show up. This is literally life and death for thousands of Americans…we just don't know which Americans yet because they are not sick yet.
    And it may be nice to get all the medical workers first, but I think it is more important to get those who have the highest risk of death if they catch it, first. 
    This is the order I would choose: Old folks homes patients first (they are currently along with the workers), then all the people working who have 3 or more major comorbidities (type 2 diabetes/advanced prediabetic, 150+ high blood pressure, high cholesterol, liver disease, kidney disease, 40+ BMI, coronary artery disease (or other major heart conditions), moderate to severe asthma/other lung conditions, thalassemia, sickle cell disease, imunocompromized, pregnancy, and cancer). And at the same time any healthcare, social workers, or law enforcement that has at least one comorbidity.
    After that, anyone over 65, anyone with one or more commodities, and any essential worker (including healthcare..).
    Then just anyone else.

  20. The Pfizer and Moderna vaccines are making the body muscle cells build the virus envelope proteins in a process never used before. Results were fully analyzed only for few hundreds people. What can go wrong?

  21. Bureaucracy and the banality of evil.

    Doing a bureaucratic pause of several weeks, while ~2000 people are dying daily of a disease they could start vaccinating against instead, falls within the definition of evil.

    There won't be any new science, no changes to the vaccine nor nothing added. Just the delays imposed by the paperwork and the indifference.

    And some people think Douglas Adams' Vogons demolishing Earth because everything was within the forms and well documented are an exaggeration.

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