Canadian researchers published in the New England Journal of Medicine that Pfizer-BioNTech vaccine showed 92.6% effectiveness with just one dose, raising question about the necessity of the second dose. Researchers Danuta Showronski and Gaston De Serres analyzed Pfizer’s data submitted to the Food and Drug Administration [FDA], opening up the possibility that the second Pfizer can be delayed or bypassed entirely. Pfizer responded to the Canadian findings saying recommendations for a second vaccine dose is based on efficacy data submitted for Emergency Use Authorization [EUA] to the FDA. Pfizer received EUA Dec. 11, 2020 with Moderna following close behind Dec. 18. Showronski and De Serres showed that Moderna’s first dose efficacy was 92.1%, questioning, again, whether the second shot was necessary, despite Moderna’s data submitted to the FDA.
When you consider the scarce supplies, at least for now, of the Pfizer and Moderna vaccines, Showronki and De Serres findings suggest that it wouldn’t hurt to distribute the second dose vaccines to first dose recipients, waiting for second doses until vaccine supplies improve. Showronksi and De Serres admit in their analysis they don’t know with one dose of Pfizer or Moderna how long neutralizing antibodies would last. Neither Pfizer nor Moderna know with two doses how long neuralizing antibodies last, assuming, in the original research that two doses were required to assure neutralizing antibodies in the indefinite future. Questions also arise whether of not the spacing between the doses in necessary at 21 days for Pfizer and 28 days for Moderna, if single doses provide 92.6% and 92.1% efficacy with a single dose. FDA officials asked Pfizer and Moderna to do more research.
FDA officials want to know also why Moderna’s vaccine, that has three times or 300% more mRNA than Pfizer. still gets about the same efficacy. If more research shows that Moderna, can lower the dose of mRNA they can get three times the amount of vaccines out of one vial from current Moderna dosing protocols, also alleviating any shortages in the supply chain. Inclement weather in the South, Southwest and East Coast has delayed the supply chain to hospitals and clinics providing vaccinations. Great Britain’s Center for Disease Control and Prevention has joined the U.S. CDC in researching whether second doses can be delayed because of Showronkski and De Serres findings at the British Columbia Centre for Disease Control and Institut National de Sante Publique du Quebec. Pfizer responded to the Canadian report that they stand by their original data staging two vaccines for optimal efficacy.
CDC officials wanted Moderna to investigate the dosing of mRNA, 300% greater than the Pfizer vaccine, giving Moderna potentially the ability stretch three vaccines out of Moderna’s current requirements. Moderna has no data to report suggesting that they can cut the dosage one third and maintain current efficacy. Most countries are scrambling to get citizens vaccinated, with vaccines in short supply. If Pfizer or Moderna can confirm that they can get three times the amount of vaccines from their initial estimates, it would give an abundant supply to many vaccine recipients. Neither Pfizer nor Moderna was willing to go out on a limb to confirm the Canadian findings that the public can do with less vaccines because the efficacy data. No one knows whether tampering with the dosages would affect the amount of neutralizing antibodies associated with the vaccines.
Showing how politics enters into purchase Covid-19 vaccines, the European Union [EU] contracted for 300 million doses of Moderna’s vaccine, despite the recent World Health Organization [WHO] approval of AstraZeneca-Oxford’s new Covid-19 vaccine. European Commission President Ursula von der Leyen finds herself still in a trade dispute with the U.K., since completing their Brexit trade deal Dec. 30, 2020. Von der Leyen isn’t making the vaccine purchase with Astra-Zeneca, which used a different technology creating the vaccine, using human adenoviruses not mRNA, like Pfizer and Moderna. Whatever the reasons, the EU hasn’t spent their euros on the U.K. based vaccine that shows 63% efficacy, far off from the Pfizer and Moderna vaccines, well over 90%. Whatever the reason for buying Moderna, U.K. Prime Minister Boris Johnson won’t be too happing with Brussels.
Buying 300 million does of Moderna’s vaccine, the European Medicines Agency {EMA] went with a proven product, not the recently approved AstraZeneca vaccine. Some EU countries like the Czech Republic, bypassed the EU altogether to buy Russia’s Sputink V vaccine, despite its questionable data on safety and effectiveness. When you consider the distribution problems in the U.S., the EU moved to flood the market with Moderna vaccines, giving EU citizens the best chance to get vaccinated. It’s doubtful that EU will see too much Pfizer vaccine due logistics, transporting it at minus 94 degrees Fahrenheit. Before distributing Moderna’s vaccine the, EMA should see whether the company would reduce the dosage, current three times the mRNA than Pfizer’s vaccine. EU regulators could turn 300 million doses potentially into 900 million doses with a little more research.
