The results of the U.S. clinical trial of the AstraZeneca SARS-CoV-2 vaccine came in today in a press release and it was extremely good news for the company. This trial was done entirely in the U.S. and was the first clinical trial performed using this vaccine that did not have a technical error. The data, from over 32,000 individuals, showed that two doses of this vaccine were 79% effective in eliminating mild disease and highly effective in preventing severe illness and death.
Potentially more important for this vaccine, there were no serious adverse events in the clinical trial and no evidence of blood clotting problems that had been suggested to be an issue in the European Union.
The major result of this trial will be to salvage the vaccine for use in most of the world. The two greatest advantages for this vaccine are its low cost and its ability to be kept in a standard refrigerator for up to six months. This makes it a vitally important vaccine in parts of the world that don’t have freezer storage or reliable refrigeration.
In the United states, however, the vaccine is almost superfluous. The company stated that it won’t be able to apply to the FDA for at least two to three weeks and expected a review in May. This would mean that the vaccine would not be available in the U.S. until the end of May, a time when the government believes it will have adequate amounts of the three currently approved vaccines for all the adults in the U.S.
Additionally, the AstraZeneca vaccine doesn’t match up well even to the Johnson and Johnson vaccine. Both are based on adenoviruses, however even with two doses, the AstraZeneca vaccine looks roughly equivalent to a single dose of the Johnson and Johnson vaccine. This suggests that it offers no advantage in the U.S. over the three vaccines that are currently approved.
Why then would AstraZeneca apply for approval of this vaccine in the United states? There are several reasons, but the most prominent one is to get the imprimatur of the United States regulators who are some of the most stringent in the world. This would go a long way to quieting concerns of regulators in other parts of the world where this vaccine is vitally needed.
Since the U.S. has reserved and paid for 300M doses of this vaccine, it can redirect them to other countries where the need is greater. Already 4M doses are being sent out: 2.5M to Mexico and 1.5M to Canada. This could change the whole vaccine dynamic in many countries in need. The herd immunity in these other countries will help prevent further spread of COVID-19 and could prevent the development of some variant viruses.
Therefore, while this is not a big event in the United States, it is a terrific day for the world community as a whole!
2 thoughts on “The AstraZeneca vaccine results in the U.S. are revealed.”
Jim, It has been brought to my attention that the vaccines have not received full approval. They are approved for emergency use which can be revoked at any time. The companies are expected to continue placebo controlled trials. So effectively, we are in the experimental treatment arm of what is still a vaccine under investigation. Any idea when full approval may be expected?
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Yes, but the final approval requires long-term safety, which should be available in 6-12 months. I till come for the RNA vaccines. JnJ may wind up as two doses at final approval. AZ-forget it! Won’t happen.