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The Covid-19 vaccine developed by the Oxford-AstraZeneca consortium should begin to be evaluated by the WHO (World Health Organization) only in February, said on Monday (28) the deputy director general Mariângela Simão, responsible for the area of access to medicines, vaccines and pharmaceuticals from the UN agency.
The main immunizer of the Brazilian government’s Covid-19 vaccination plan, the Oxford-AstraZeneca vaccine is seen as one of the best options for less developed countries, because it allows mass production and is cheaper and easier to distribute than those developed by Pfizer and Moderna (which must be stored at minus 70 degrees Celsius).
However, according to Mariângela Simão, the WHO does not yet have the full results of clinical trials on hand for the immunizer, which is being manufactured in different countries and tested in at least six, including the United Kingdom, Brazil, South Africa and the United States.
The WHO assessment date does not necessarily affect the authorization date of Anvisa (Brazilian regulatory agency), says Dirceu Barbano, who chaired the agency from 2011 to 2014. Although it can be used by individual countries, the WHO recommendation is mandatory just for shopping. made by the organization itself or through its funds.
The former president of Anvisa says the impact of a delay should be greater for less structured countries, which do not have strong regulatory agencies and depend on the evaluation of the UN body. “Brazil, the United States and European countries, among others, which have their own structure, tend to be more agile in decision-making than the WHO,” he says.
Barbano notes, however, that definitive conclusions depend on access to full data from clinical trials. “It is not possible to evaluate statistically with only one part of the studies,” he says. Without all the results, the option would be an emergency use request, for application in specific groups.
According to Anvisa’s table updated on December 23, the agency received on the 22nd primary data on the efficacy and safety of the vaccine, which is “awaiting analysis.” Earlier this month, the Lancet magazine published a peer-reviewed article that indicated 70% effectiveness, based on data from three countries: Brazil, the UK and South Africa.
The results of the clinical trials were reevaluated after experts discovered strange data published in late November, showing better results among those who had received only one dose of the vaccine. The article makes it clear that there are still gaps to be clarified, such as, for example, the best dosage regimen and effectiveness in older adults.
The Brazilian government ordered 100.4 million doses of the AstraZeneca immunizer and 46 million of Coronavac; the acquisition of more doses is being negotiated. 8 million doses of Pfizer are also being negotiated, which has already obtained emergency authorization in other countries.
Last week, Fiocruz, responsible for the production in Brazil of the Oxford-AstraZeneca vaccine, stated that it would begin to be delivered to the Ministry of Health as of February 8. On Monday, after the WHO statement that the analysis would only begin in February, Fiocruz said its schedule is being maintained.
In another interview, the institution’s vice president for innovations, Marco Krieger, told Folha that Fiocruz should ask Anvisa to register the vaccine before January 15.
