CAJICA, Colombia – Brazil’s health care surveillance agency, Anvisa, granted the first two emergency approvals for COVID-19 vaccines on Sunday, Jan. 17, giving the green light to Sinovac Biotech Ltd.’s Coronavac and to Covishield, developed by Astrazeneca plc and the University of Oxford.
Both vaccines will be manufactured in the country. The Butantan Institute is set to manufacture and distribute Coronavac, an inactivated virus vaccine. The Oswaldo Cruz Foundation (Fiocruz) will work with the Serum Institute of India to produce Covishield, the two-shot viral vector vaccine also known as AZD-1222 or COVID-19 Vaccine Astrazeneca in the U.K.
“Anvisa's approval proves that we have a safe and effective vaccine to make available to the population; and we are not saving any efforts to make it happen as quickly as possible," said Mauricio Zuma, director of the Institute of Technology in Immunobiologicals, an arm of Fiocruz.
Butantan has about 11 million doses of Coronavac ready for distribution, but it is unclear when Covishield be available in Brazil. Authorities are coordinating shipments of about 2 million doses from India and supplies of active pharmaceutical ingredients (APIs) from China to manufacture the vaccine domestically, said Fiocruz.
Coronavac: Vaccination started
Vaccinations in the state of Sao Paulo started virtually minutes after Anvisa granted its approval, which was conditioned on Butantan submitting additional documents and information before the end of February.
“This commitment term determines that, until February 28, complementation of immunogenicity studies should be carried out and presented to Anvisa, as approved in the phase III vaccine clinical trial design,” said the regulator.
“These documents, therefore, should complement the information regarding the immunity granted to volunteers who received the vaccine in the third phase of clinical development. The data is essential to conclude the duration of the immune response in vaccinated individuals,” Anvisa said.
Coronavac's results in Brazil generated controversy after Butantan offered some additional information on the efficacy of the vaccine, in effect lowering an announced efficacy rate of 78% down to a little more than 50% on all cases. Despite lower efficacy, the vaccine topped the required 50% efficacy recommended by the World Health Organization (WHO).
“Both Fiocruz and the Butantan Institute must continue their studies and generate data to allow health registration at Anvisa,” said the federal agency. “Likewise, both need to maintain vaccine safety monitoring, which is critical to ensuring that the benefits continue to outweigh the risks for people receiving COVID-19 vaccines.”
Sunday´s unanimous decision by Anvisa’s directors to grant emergency approval to the two vaccines settled a fierce political dispute between President Jair Bolsonaro and his rival, Sao Paulo Governor Joao Doria, about which vaccine to use. Brazil has the third highest incidence of COVID-19 in the world so it is unlikely that a single vaccine would be enough.
Minutes after the approval, Mônica Calazans, a 54-year-old nurse in Sao Paulo suffering from obesity, diabetes and hypertension, was the first person to receive the Coronavac vaccine in the country after the phase III trials. It is not yet clear how vaccines will be distributed across the country, with different states adopting different strategies.
“Despite a world class tradition in mass vaccination, the country does not have yet a national program of vaccination for the SARS-CoV-2,” Andre Lobato, a China researcher in the Center for International Relations in Fiocruz, told BioWorld. “Today's inoculation is of course a start.
“It is a big day for Brazilian and Chinese relations,” added Lobato. “I hope that this vaccine is a success and that it helps to neutralize anti-China feelings, fostering new days of biotechnological collaboration between these two populous and megadiverse countries.”
The emergency approval is a temporary measure while companies continue moving along the regular approval pathway.
“The emergency use authorization procedure assesses the suitability of vaccine candidates against COVID-19 for use during the current public health emergency, in order to minimize, as quickly as possible, the impacts of the pandemic,” according to Anvisa. “Temporary authorizations for emergency use are not approvals for marketing, distribution and use. In other words, health registration has not yet been granted.”
Sputnik V: A setback
A day before granting the two approvals, Anvisa also turned down a request to register Sputnik V, the two-shot human adenovirus-based vaccine developed by Russia’s Gamaleya National Center of Epidemiology and Microbiology.
“The request was returned to the company for not meeting the minimum criteria, especially due to the lack of authorization to conduct phase III clinical trials (…) and issues related to good manufacturing practices,” said Anvisa.
“The agency clarifies that it is not enough to request a phase III clinical trial authorization to be filed to request emergency use. It is necessary that such studies are underway in the country, in addition to other conditioning measures already foreseen.”
União Química Farmacêutica Nacional, from Sao Paulo, the company that applied to register Sputnik V in Brazil, issued a statement in which it explained that Anvisa only requested additional information and that it plans to provide it shortly.
“This procedure is standard with regulatory agencies and does not mean that the registration has been denied,” said the company.
Sputnik V is already registered in Argentina, Bolivia, Venezuela, Paraguay, Algeria, Palestine, Serbia and Belarus, according to União Química. The vaccine is also approved in Russia.
With about 8.5 million cases of COVID-19 and 209,000 deaths, Brazil has the third highest tally in the world, behind India and the U.S. The country has a population of about 209 million people.