Pfizer’s Not To Be OutDone

Last week Pfizer announced its COVID-19 vaccine was 90% effective. Later in the week Moderna one-upped them by announcing that their vaccine, also based on messenger RNA (mRNA) was 95% effective. The Associated Press reports that Pfizer has riposted:

Pfizer says that more interim results from its ongoing coronavirus vaccine study suggest the shots are 95% effective and that the vaccine protects older people most at risk of dying from COVID-19.

The announcement, just a week after Pfizer first revealed promising preliminary results, comes as the company is preparing within days to formally ask U.S. regulators to allow emergency use of the vaccine.

Pfizer initially had estimated its vaccine, developed with German partner BioNTech, was more than 90% effective after 94 infections had been counted. With Wednesday’s announcement, the company now has accumulated 170 infections in the study — and said only eight of them occurred in volunteers who got the actual vaccine rather than a dummy shot. One of those eight developed severe disease, the company said.

The company has not yet released detailed data on its study, and results have not been analyzed by independent experts.

Pfizer said its vaccine was more than 94% effective in adults over age 65, though it is not clear how the company determined effectiveness in older adults, with only eight infections in the vaccinated group to analyze and no breakdown provided of those people’s ages.

Earlier this week Moderna, Inc. announced that its experimental vaccine appears to be 94.5% effective after an interim analysis of its late-stage study.

Pfizer says it now has the data on the vaccine’s safety needed to seek emergency authorization from the Food and Drug Administration.

The company didn’t disclose safety details but said no serious vaccine side effects have been reported, with the most common problem being fatigue after the second vaccine dose, affecting about 4% of participants.

The study has enrolled nearly 44,000 people in the U.S. and five other countries. The trial will continue to collect safety and efficacy data on volunteers for two more years.

Pfizer and BioNTech said they expect to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion doses in 2021.

That’s all good news and I hope it proves out.

As I reflected on the discussion in comments to my post yesterday, in which I argued that, given the novelty of the vaccine’s modality and the state of knowledge about both the vaccine and the virus, it would be prudent to do a little more testing before mass distribution while everyone else argued that mass inoculations should begin immediately because it might save lives, that there really is no right answer. It depends entirely on the assessment of relative risks in the absence of information.

A couple of more points that should be made. Even with multiple companies producing vaccines, it will still take years to inoculate the number of people envisioned whether that’s 60% of the world’s population or more. And that will probably require substantial U. S. subsidies for other countries and making inoculations mandatory as smallpox was.

13 comments… add one
  • Grey Shambler Link

    mandatory?

    You can’t be serious.
    Some people out here would shoot you before they let you put that frankenmed in their arm.

  • Unless you believe that 60% or more of people in the U. S. will be inoculated voluntarily, is there any other way of achieving the presumed objectives?

    This would appear to be another opportunity for a publicity campaign.

    There’s a white paper here on the history of vaccination laws in the U. S. TL;DR version is we had smallpox vaccination requirement laws in all states; states have the authority to mandate vaccinations. Entry into the U. S. can be subject to vaccination requirements.

  • CuriousOnlooker Link

    I cannot imagine mandatory vaccination before complete FDA approval; not just an EUA.

    There are other vaccines in the pipeline that do not involve mRNA.

    They are already doing PSA’s on the radio about a vaccine.

  • Those are good points, CuriousOnlooker, but it returns to the point I made in the comment above. Can you actually achieve “herd immunity” in the absence of mandatory vaccination?

  • steve Link

    Our number of admissions this week were 50% higher than last week. We now have more people under 61 y/o being admitted than over 61, 52% vs 48%. We can vaccinate the older population which will cut down deaths, but if we still have this many hospitalizations then our economy isn’t going back to normal for a while. Really need some good research on who is ending up in the hospital. There are some out there bout need refining.

    Steve

  • I agree with that plea wholeheartedly, steve. I would think that at this point we would have sufficient data to start making much better policy decisions. In particular it would be helpful to know more about

    • who is most susceptible to the virus
    • what settings are most conducive to transmission of the virus
    • what behaviors are most conducive to transmission of the virus
    • who is most likely to require hospitalization

    but, apparently, we’re still operating with a seat of the pants approach. I still think that more and better epidemiological analysis is needed.

  • PD Shaw Link

    About 50% of Americans are vaccinated for the flu every year, and that vaccine is only about 45% effective on average. I think that’s almost entirely voluntary. And right now there are drive-in facilities around my city where I can either get the flu vaccine or a covid testing, which could provide the infrastructure for administering a covid vaccine.

    I don’t think I’ve ever gotten a flu shot, since I don’t much see the need personally and I’m too lazy. I’m also one of those parents that rolled their eyes about the mandatory chick pox vaccine. I would take this vaccine if offered because there is an observable public health risk and I’m not aware of any particular health risks identified with the Pfizer or Moderna vaccines. I think the demand will exceed the supply for quite awhile to worry about when it should be mandated.

    Moderna started vaccinating test subjects in March, and phase 3 started in July. That seems like enough time for adverse reactions to be observed.

  • CuriousOnlooker Link

    “That seems like enough time for adverse reactions to be observed’

    It is not time — but the number of people vaccinated so far is not enough to find rare adverse reactions.

    For example, a particular H1N1 vaccine was found to cause narcolepsy in 1 of 12000.

    https://www.who.int/vaccine_safety/committee/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_statement/en/

    Given the vaccine has been given to about 40000 people (Moderna + Pfizer), any adverse reaction that occurs less than 1 in 40000 is unlikely to have been detected. The only way to find if those adverse reactions exist is to give it to several million people.

    Now I think the benefits of a 95% risk reduction in a disease that has an IFR of 1% and a R0 of 3.5 far outweighs a potential 0.025% risk of an adverse reaction from a vaccine.

  • PD Shaw Link

    @CuriousOnlooker, I agree. I could have worded that better. I do operate under the assumption that rare, but serious reactions are possible with any vaccine.

    Another example is the polio vaccine, the Salk version suffered from a manufacturing defect at one company (Cutter) which permitted a live strain of the virus to remain in the vaccine, causing “40,000 cases of polio, leaving 200 children with varying degrees of paralysis and killing 10.” Public health switched to the Sabin version, which might provide better immunity anyway, but can result “in occasional cases of polio (still causing paralysis in six to eight children every year in the 1980s and 1990s, when a modified Salk vaccine was re-introduced).”

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1383764/#:~:text=In%20April%201955%20more%20than,polio%20had%20to%20be%20abandoned.

    Added: I’ve read one explanation that causing a few cases of paralysis a year was acceptable with the Sabin vaccine until polio became so rare the trade-offs became entirely unacceptable. But the new Salk might provide less effective immunity.

  • steve Link

    The real risk of complications as we know is inadequately tested vaccines can lead to the creation of zombies. In which case you would still survive but your diet would change drastically. Tradeoffs!

    Steve

  • steve Link

    “I don’t think I’ve ever gotten a flu shot,”

    Never did either until I got it bad one year. Temp 105. Could not walk. Had to crawl to the bathroom. Every year since I got the vaccine.

    Steve

  • PD Shaw Link

    @steve, your workplace doesn’t require a flu shot? I’m not sure if my wife’s hospital requires it now, but for the last 10-15 years it seems like there have various nudges, incentives, payments, vaccination social-gatherings that they use to get employees vaccinated without actually requiring it. They may have crossed the line at some point.

    Working from home, particularly since the pandemic, I’m rarely very close to anybody outside of my family, and two out of three of them are vaccinated for the flu. I’m probably not an ideal person for the COVID vaccine either.

  • I got a flu shot a couple of weeks ago and had a reaction to it I’ve never had before. 12 hours after getting it, it really knocked me on my rear end. That didn’t last long, actually only an hour or so. But I did have a reaction which never happened before.

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