How is the approval of vaccines against COVID-19 progressing?

As we recently reported, the United States Food and Drug Administration (FDA) has recommended the Pfizer-BioNtech candidate's emergency use authorization. This gives us an excellent excuse to examine the progress of the approval of the main vaccines against COVID-19 that have presented their results so far.

Pfizer-BioNtech vaccines to be distributed upon approval in North America

The Pfizer-BioNtech candidate was approved for emergency use by the UK Medicines and Healthcare Products Regulatory Agency last week. This Tuesday he began his mass vaccination program and a contraindication was also detected with two cases that developed allergy symptoms after receiving the drug.

Despite this, FDA experts have reached a conclusion similar to that of the British regulator: the benefits of the Pfizer-BioNtech vaccine outweigh the risks. With 17 votes in favor, four against and one abstention, the Advisory Committee on Vaccines and Related Biologics (CBER) considers it safe to administer COVID-19 vaccines to people over 15 years of age after formalizing approval.

Canada has also approved emergency use of the candidate, and it is expected to begin distribution next week. In the United States, it is expected to start this Saturday, two days after the FDA statement.

Moderna vaccine: minimum four months of immunity against SARS-CoV-2

As many know, Moderna developed its vaccine also with messenger RNA technology, although reports of its effectiveness so far are referred to in press releases. So far, they suggest it was able to prevent COVID-19 infection in 94.1 percent of the trial volunteers.

On December 3, they published in the New England Journal of Medicine the details about the presence of antibodies against SARS-CoV-2 in the blood. These could remain effective for at least four months after the first injection, based on data collected so far.

However, Soumya Swaminathan, a scientist at the World Health Organization (WHO) still considers it necessary to wait for the final efficacy and safety profile to be able to give a verdict. He said this in reference to the approval of both Pfizer-BioNtech and Moderna's COVID-19 vaccines.

Waiting for Oxford-AstraZeneca

The vaccine developed jointly by the University of Oxford and the AstraZeneca laboratory has been one of the most followed by the media for its broad benefits. First, it promises to be the most economical among COVID-19 vaccines once approved.

But particularly in the United States, the FDA does not appear to be very happy with the association's management of the project. Sources cited by the New York Times recall the setbacks during phase III trials and the excessive tightness in details about side effects that they previously reported were not associated with their drug. Despite the fact that in Europe trials were quickly restarted after two cases, the United States took greater precautions.

Another point that has been discussed a lot is that of its effectiveness, which seems to be greater in lower doses than initially stipulated. As we reported in a previous note, among people who received the standard dose it was 62 percent effective. In contrast, when a lower starting dose was applied, the effectiveness reached 90 percent.

Despite the controversy, this is one of the vaccines against COVID-19 with the highest expectations in its approval, due to the comforts it would offer. It would not only be an effective and safe drug, but also easy to store and transport by not requiring freezing conditions.

References:

The week of American vaccines, and the European? https://www.newtral.es/vacunas-covid-pfizer-moderna-aprobadas-oxfor/20201210/

Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. https://www.nejm.org/doi/full/10.1056/NEJMc2032195

PFIZER-BIONTECH COVID-19 VACCINE (BNT162, PF-07302048). https://www.fda.gov/media/144246/download