Science

Like Coronavac, the Oxford vaccine has disclosure errors – 01/14/2021 – Equilíbrio e Saúde

The coronavac vaccine wasn’t the only one having issues disclosing its data in Brazil. Communication errors have also created confusion about the other immunizer to be used in the country from next week, the one developed by Oxford University with pharmaceutical company AstraZeneca, although the two products are efficient and safe.

Since the first international announcement in November, AstraZeneca has been criticized by scholars and professionals in the field. It started with a press release citing three different potencies for the immunizer (all over 50% deemed necessary).

The 90% effectiveness relates to a study group that took half a dose and then a full dose. 62% to another larger group who took two whole doses. After all, the index of 70% corresponds to the sum of the two groups.

The fact that this first group received half a dose raised doubts among professionals, as the practice is unusual in this type of study, and led the company to admit that a dosage error had occurred. To date, it is not clear why those who took the smallest dose had a better result.

A number of other loopholes in the original statement were also pointed out at the time, such as the lack of absolute numbers of Covid-19 cases in the different groups and the reason why the results of different clinical studies from the UK and Brazil were combined .

The company’s shares fell, and executives had to hold conference calls to explain themselves to Wall Street analysts and raise questions about not disclosing this information to the public. The full study was published later in December in The Lancet.

“The Oxford vaccine has raised many doubts, there was also a communication error, the paper is confusing. So there is still no FDA approval [agência dos EUA]”Says epidemiologist Denise Garrett, who worked at the North American Center for Disease Control and Prevention.

The vaccine has already been approved in seven countries (UK, India, Mexico, Morocco, Argentina, Ecuador and El Salvador). Here it is analyzed together with Coronavac by Anvisa, which has collected more data from both Fiocruz and the Instituto Butantan and has to decide on Sunday (17) whether or not to publish both products.

On the same day, the first 2 million doses of the vaccine to be distributed in Brazil should come from India. Then Fiocruz will wait for the inputs from China to start domestic production of 100 million cans by July. In the second half, the technology will be imported and another 110 million will be manufactured.

Meanwhile, the Brazilian lay public remains unsettled. So far, none of the authorities responsible for the study or manufacture of the immunizer in the country have made public announcements or formally cleared the specs, as Butantane and the São Paulo government have done, despite much criticism.

The Institute and Governor João Doria (PSDB), who is waging a political battle with President Jair Bolsonaro, postponed the announcement twice and released partial results last week that cast doubt. They had to clear the confusion by convening a press conference with renowned scientists on Tuesday (12).

In the case of the Oxford vaccine, Fiocruz does not participate directly in clinical studies carried out by AstraZeneca and coordinated by Unifesp in Brazil. For this reason, “it has published the information that has already been published in a scientific journal and widely disseminated by the producers and coordinators of the studies”.

According to Unifesp (Federal University of São Paulo), Brazil is only part of the global study and “all data dissemination must be carried out by Oxford University in collaboration with AstraZeneca”.

When asked, the pharmaceutical company’s headquarters in Brazil reported that it made the detailed protocol and design of the clinical trial available on its website, in addition to the worldwide announcement in November and the publication of the data in the Lancet.

“Good clinical practice and regulatory standards require that the information we share be tightly controlled so as not to unduly affect or bias clinical trials,” he said in a note.

Recently Fiocruz reported in a statement that after the first dose, the vaccine was 73% effective and 100% effective at preventing hospital stays. However, when asked, neither the Foundation nor Unifesp were able to detail the data. AstraZeneca replied that this was the result of a complementary analysis taking into account a period from 22 days to 12 weeks after the first dose.

For professionals in the field, the lack of clear information at a time of politicization and denial of science can hinder vaccination in the country, depending on people’s compliance with the regulations.

“Transparency is important, otherwise there is a lot of uncertainty and doubt. Of course, the population doesn’t need all the details, but the basics are security and the level of protection that need to be clearly communicated, ”says Denise Garrett.

Natalia Pasternak, President of Instituto Questão de Ciência, recalls that with the pandemic, data on vaccines guided citizens’ decisions. “There is no longer any choice between explaining or not explaining. We have to explain and in a way that the population understands without hiding any uncertainties, ”he says.

She says that in the case of the Oxford immunizer, “a serious disclosure error has occurred that has not been resolved to date”. “It’s a priority vaccine in Brazil, along with Coronavac. So it would be very instructive if Fiocruz, who is responsible for launching and manufacturing, explained the data.”

There was also a lack of transparency for Hillegonda Maria Novaes, coordinator of the epidemiological monitoring center at Hospital das Clínicas, USP, but this is a common problem.

“It seems that Fiocruz and butantane are not transparent, but neither are others. When you look at the data, how it’s made, how the disclosures went, all large companies are in trouble. There are always interests, implications, meanings, ”he says.

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