The laboratory, which developed the antigen together with the University of Oxford, will initiate procedures with the FDA. But because its clinical tests were not carried out in the North American country, the process could be extended
AstraZeneca is the third laboratory to seek rapid approval of the COVID-19 vaccine from the FDA (the federal food and drug administration) in the United States. The difference is that it will be the first case whose evidence of effectiveness tests has been collected abroad.
AstraZeneca clinical trials were conducted in the UK and Brazil. On average, their vaccine is 70 percent effective (well below Pfizer and Moderna, which reported above 90 percent effectiveness). But the key is the fact that this figure is an average. AstraZeneca tested two different doses of the vaccine. In one of the tests, 8,900 participants received two full doses of the vaccine, a month apart between the first and second applications. The result was 62 percent effective. The second trial was carried out with 2700 participants, who received a half initial dose and a full dose a month. In that case, the efficacy was 90 percent. It is assumed that, if approved, this would be the modality accepted by the FDA. In neither trial were there any worrisome side effects.
“We are beginning to officially submit the results of the clinical trials that we have collected around the world in order to obtain approvals for emergency or use under conditions in various agencies, including the FDA,” reads the press release released by AstraZeneca.
The lab has one foot in a clinical trial of the initial half-dose vaccine in the United States. It is assumed that 40 thousand people must prove it in this country, although for the moment there are 10 thousand volunteers in the program. In September these tests were stopped in this country due to neurological problems developed by a patient, which is unknown if they were related to the vaccine. There are no known results, not even partial, of this clinical study, so for the moment, these tests will be out of the FDA’s consideration.
The complication to receive approval in the United States not only lies in the fact that there are no tests completed in this country, but the FDA usually requires tests on at least 30,000 people. So far, around the world, AstraZeneca would have tested its vaccine on 24,000 people. Of these, 131 people contracted the virus after receiving the vaccine, but the laboratory has not publicly revealed whether these volunteers had received the placebo or the vaccine. The only official information is that of the 131 infected, none experienced a severe case of COVID 19 that required hospitalization.
This particular vaccine generated a lot of hype because it is cheaper and easier to transport than those developed by Pfizer and Moderna. The AstraZeneca vaccine can be kept usable for six months only under refrigeration in normal refrigerators. In addition, the laboratory assured that they are in a position to produce 3 billion doses in the next 12 months.
“AstraZeneca and Oxford have developed an inexpensive vaccine, easy to mass produce, that can be stored and transported without major complications (…) this makes it simple to distribute throughout the world, including low-resource sites,” it said in a statement. Richard Hatchett, CEO of the Coalition for Innovations in Epidemic Preparedness.
This vaccine, developed at the prestigious University of Oxford, uses a different method than Pfizer and Moderna. It is a weakened version of the common flu, containing certain genetic material from the coronavirus.
The United States government invested in the development of this vaccine and months ago purchased 300 million doses valued at more than a billion dollars.