Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

What Do the Moderna Vaccine Candidate Press Releases Tell Us?


 

I had thought that the vaccine studies would only be recruiting people up to 55 years old, which was the age limit on the phase 1 studies, but there is significant representation of people over 65 and people with serious comorbidities. This is excellent news.

 

According to one press release from Moderna:

The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.

 

The other important concern I had was the need to store the vaccine at around -80 degrees C, which would limit access for a lot of people, even in America. From another press release, dated 4 minutes earlier, Moderna:

today announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.

 

There is an excellent analysis of the press release on preliminary efficacy results at STAT News, which has been ahead of the rest of the media in recognizing the serious nature of this pandemic.

 

It is important to remember that a press release, even about something this serious, is a commercial, intended to promote the company’s product. The information provided by Moderna in the press releases has not been peer reviewed. The numbers may change as mistakes are caught and conclusions are examined. That is OK, because there will be thorough analysis of the results before any vaccine candidate is approved for use outside of these experiments.

 

How will we know when a vaccine is safe and effective? I provided my criteria in August, when I wrote about a vaccine approved by President Putin, based on inadequate research:

I want to see recommendation of a vaccine by the people who know the most about vaccines – Paul Offit, Michael Osterholm, Peter Hotez, and Anthony Fauci. They need to be able to see all of the evidence. The only reasonable conclusion about a refusal to share the evidence with any of them is that there is something bad being hidden. These are not politicians. None of these medical experts have shown signs of being influenced by political pressure.

 

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Comments

  1. RM, Always good to hear from you. I am not sure how to process your cautious optimism.

    Stay healthy.

    • Greg,

      Good to hear from you, too.

      Things are looking much better for the winter with the potential for two vaccine candidates being approved before the end of the year. There are several reasons to be cautious and several reasons to be optimistic.

      There was a press release last Monday with preliminary results on the Pfizer/BioNTech vaccine candidate. Both vaccine candidates appear to be over 90% effective, but these are preliminary numbers. As with any new treatment/vaccine candidate, the initial results are expected to be better than the results from widespread use.

      The numbers and the rates of infections have increased a lot, especially where you are, so we need something. A large portion of the population are unreasonably political, about something that should not be political, and refuse to wear masks. They don’t appear to care whom they infect. They do not appear to have any respect for their elders. They do not appear to have any respect for life or health.

      Last Monday, when similar results were part of a press release from Pfizer/BioNTech, one of the concerns Michael Osterholm had about that vaccine candidate was:

      “I don’t want to dampen any enthusiasm for this vaccine. I just want us to be realistic,” Osterholm said. “For a vaccine to really have maximal impact, it’s going to have to also reduce severe illness and death. And we just don’t know yet.”

      https://www.statnews.com/2020/11/09/covid-19-vaccine-from-pfizer-and-biontech-is-strongly-effective-early-data-from-large-trial-indicate/

      The efficacy press release from this morning helps to address those concerns, although these numbers are still just preliminary and a small sample size.

      A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group.

      https://investors.modernatx.com/news-releases/news-release-details/modernas-covid-19-vaccine-candidate-meets-its-primary-efficacy

      This morning’s efficacy press release states that the preliminary statistical analysis of 90 COVID-19 cases in the placebo group and 5 in the intervention group resulted in a p value of <0.0001. One of my criticisms of medical research is the comfort we have in accepting results that are expected to occur by chance in about 5% of studies, which is the p value of p <0.05. While these are still very small numbers, and small numbers are expected to produce misleading results, the probability of these results being merely coincidental, especially for two different vaccine candidates in two separate studies, with about 75,000 participants, reinforces my optimism. Also, since both vaccine candidates use mRNA to provide immunity, the ability of the Moderna vaccine candidate to remain stable at normal vaccine storage temperatures, rather than requiring -80' C, suggests that the Pfizer/BioNTech will be able to remain stable at much higher temperatures than -80' C. This would make it much easier to vaccinate the most vulnerable quickly.

      Yes. There is always the possibility of fraud, but rigorous analysis of the results should help identify any impropriety.

      If the FDA approves either candidate, or both candidates, there should be 50 - 150 million of doses ready to be delivered at the time of the approval(s).

      There is still a lot to learn, but this is much better than we had any reason to expect, since there has never been a successful coronavirus vaccine for humans, in spite of attempts for both SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome).

      The biggest question is, How long will immunity from vaccination last?

      We may need to be vaccinated every year, or even every 6 months. Part of that will depend on how many people are vaccinated and whether this coronavirus continues to spread among people. SARS did not, but SARS was not spread by asymptomatic, pre-symptomatic, or minimally symptomatic people.

      Based on the current increase in COVID-19 diagnoses, there should be a lot more efficacy data available before any candidate receives approval from the FDA.

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