The pharmaceutical Pfizer said on Friday (16) that it can apply for approval for the emergency use in the United States of its vaccine candidate to combat Covid-19, which is being developed together with the German BioNTech SE, according to the Reuters agency.
Based on the enrollment for the vaccine test, which is in phase 3, and the dosage rate, Pfizer hopes to have data to prove the safety of the immunizer in the third week of November, said executive director Albert Bourla in a statement .
Pfizer had previously said it expected final-stage test data in October.
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According to the World Health Organization (WHO), there are 193 vaccines being tested against the disease, 42 of which are in clinical trials and 151 in the preclinical stage.
The American drug regulatory agency, FDA, also said, according to Reuters, that it stipulates the presentation of at least two months of safety data before authorizing the emergency use of any experimental vaccine against coronavirus.
Covid-19: US drugmaker says it can produce vaccine in November
On 2 October, WHO Director-General Tedros Adhanom Ghebreyesus announced that manufacturers of vaccines tested against Covid-19 can now apply for approval for their emergency use.
The criteria recommended by WHO for governments to consider before authorizing emergency use are:
- Only vaccines that have already gone through phases 2 or 3 of testing and that have received authorization from a national regulatory agency can be submitted for evaluation.
- The preference is that these trials were carried out with a control group (which receives an inactive substance, the placebo) and with “double-blind” (which is when neither the volunteers nor the scientists know who got the vaccine and who got the placebo).
- Scientists must be able to prove, according to the best available evidence, that the level of antibodies developed by applying the vaccine provides protection against the disease. This data is not yet known by science.
- There must be a sufficient number of participants in the trials for the study to be able to have 80% statistical power (chance) to predict adverse effects that may occur in the proportion of one per thousand people.
- If the vaccine presented needs to be stored below 2 ° C, it must be kept for at least 6 months at a temperature between 2 ° C and 8 ° C. Because of the emergence of Covid, exceptions to this rule can be considered. In addition, scientists need to include data that show the stability of the vaccine if it is stored at a temperature of 2 ° C to 8 ° C.