After omicron, Anvisa requires evaluation of vaccine efficacy against variants

Anvisa (National Health Surveillance Agency) demanded that laboratories assess the effectiveness of the vaccine against Covid-19 in the face of new variants.

To do so, the agency asked vaccine developers for information about ongoing studies. The letter was sent this Wednesday (1st) to the laboratories that have approved vaccines in Brazil: Pfizer, Instituto Butantan, Fiocruz and Janssen.

Anvisa said, in a note, that it is actively working with international regulators and developers of immunizing agents to enable a quick action on potential impacts of the new omicron variant in vaccines against Covid-19.

“Anvisa requires, for authorized vaccines, that developers monitor and assess the impact of variants on the efficacy and effectiveness of immunizing agents. It should be noted, however, that these studies require time, as it is necessary to obtain genetic information and samples of patients to then carry out the tests and analysis,” he said.

The agency’s expectation is that, in the coming weeks, data from the initial assessments will be available. So far, these impacts are not known.

According to Anvisa, the time is for caution. This is because, so far, what is known is that vaccines remain effective in preventing Covid-19 and serious clinical outcomes, including hospitalization and death.

The agency believes that the best thing to do is for the population to get vaccinated or receive the booster of the immunizing agent. In addition to maintaining prevention measures, such as the use of masks, hand hygiene and social distance.

“Anvisa is committed to working together with the international authorities and the companies involved to allow updates to the vaccines, if necessary, to be carried out quickly, maintaining the profile of quality, efficacy and safety,” he said in a statement.

Like sheet showed, laboratories have been doing tests to evaluate the vaccine’s effect against the omicron variant, a potentially more transmissible strain of Covid-19, initially identified in South Africa.

The president of Pfizer in Brazil, Marta Díez, told the sheet that the pharmaceutical company is still evaluating whether its vaccine loses strength in contact with the omicron. The idea is for the results to be released “in the coming weeks” in December.

She said that the new contract with the Ministry of Health provides for the delivery of vaccines against Covid adapted to the new variants of the coronavirus.

Formalized on Monday (29), the agreement with the federal government guarantees Brazil 100 million doses of the immunizing agent in 2022, with an option to buy another 50 million units.

Janssen is also evaluating the effectiveness of its omicron vaccine. “We have begun work to design and develop a new omicron vaccine and will rapidly progress into clinical trials if necessary,” said Mathai Mammen, global research director for the pharmaceutical unit of Johnson & Johnson.