SÃO PAULO, BRAZIL – São Paulo State Governor João Doria announced on Monday that the state vaccination program against the novel coronavirus will begin on January 25th, despite the fact that there is no vaccine registered by the National Health Regulatory Agency (ANVISA), which is a prerequisite for the administration of any immunizer in Brazil.
If authorized, the Coronavac, developed by the Butantan Institute in partnership with the Chinese laboratory Sinovac, will be initially administered free of charge to healthcare professionals, people over 60 years of age, indigenous and quilombolas, totaling over nine million people who should be administered two doses each.
According to experts, the governor’s announcement, the first of its kind in Latin America, is putting pressure on ANVISA, which has not even received the safety and efficacy data of phase 3 trials of the Chinese vaccine – the last stage of the study; such data that must be submitted by the São Paulo government by no later than December 15th.
Hours after Doria’s announcement, ANVISA released a note stating that it had not received any phase 3 data, and detailing the Coronavac’s registration process: so far only phase 1 data have been completely analyzed. Phase 2, the reports of which were sent to the agency on November 20th, is still under examination, which means that the fast track schedule advocated by the governor to have the immunizer approved on January 25th may not correspond to ANVISA’s internal procedures.
Bolsonaro also commented on social media, saying only that “if there is ANVISA certification (scientific guidelines and legal precepts) the Brazilian government will offer the vaccine to the whole population free of charge and it will not be mandatory.”
The governor made a point of emphasizing that “Brazil is in a hurry (…) people are dying every day”. “We are not turning our backs on the national immunization plan [which should begin in March], but we need to be more agile,” he said during an interview at the Bandeirantes Palace.
“Doria’s announcement may be perceived as pressure on ANVISA to provide a quick response to something that has not yet been submitted,” said microbiologist Natalia Pasternak.
She argues that the agency “should not be pressured – neither by the Federal nor by the State Government”, so that it may “make a technical and elaborate decision”. Asked if the period of a little more than a month is enough for the examination of the Coronavac’s results, the researcher states that everything depends on “the size of the team available at ANVISA to assess the data”.
The coming days will be decisive for the future of the Coronavac and the São Paulo vaccination program. “If the data they provide to the regulatory agency on December 15th are robust and solid, to ensure a proven good efficacy, this calendar could be maintained and the campaign could begin in January”, says Mellanie Fontes-Dutra, coordinator of the Covid-19 Analysis Network.
Should the results not be satisfactory and the regulatory agency deny authorization, Doria’s plans may fail – the case could wind up in court. She stresses that “there is no immunization without ANVISA’s endorsement.” “It is essential that this matter be always analyzed from a technical and scientific standpoint,” she said.
Preliminary data submitted by Doria – quoting The Lancet medical journal – show an immune response in 97% of subjects (which is not the same as protection against the virus). According to the law related to the coronavirus pandemic, an unregistered drug can be used on an experimental basis to immunize the population if it is approved by regulatory bodies in the U.S., European Union or Asia.
In this case, the ANVISA could grant an emergency authorization, without a final endorsement. In any event, so far there is no legal way to implement a vaccine in Brazil without the agency’s approval.
However, Bolsonaro has recently challenged the transparency of ANVISA’s decisions. He appointed retired Army Lieutenant Colonel Jorge Luiz Kormann to join one of the agency’s boards – the appointee has yet to be rataified by the Senate. The goal is to have greater control over the agency’s vaccine policy, by placing more people the President’s “trusts” in the agency.
According to a Reuters report, in June, when the Ministry of Health stopped releasing complete data on the pandemic, the military members of the Ministry worked to conceal these statistics. Later, in early November, the agency suspended the Coronavac trials following an “adverse event” unrelated to the trials, not consulting the Butatan about the occurrence, which also sparked criticism of a potential politicization of the agency. At the time, the President commemorated the pause on social media.
Logistics challenge
Asked about the involvement of private clinics in the vaccination calendar, Doria stated that they can participate, but free of charge and providing universal care. “This vaccine can not be used in a private way or with a charge,” said João Gabbardo, executive coordinator of the Covid-19 Contingency Center.
The São Paulo governor’s plan has already aroused concern in some mayors of the state, who say they do not have the infrastructure or resources needed to start vaccination this early. According to Geraldo Sobrinho, president of the São Paulo Council of Municipal Health Secretaries, there is the concern regarding waiting lines and lack of funds to pay overtime to vaccination teams (given that this is conducted out of regular working hours).
To meet the demand, the governor announced that he will double the number of vaccination posts, from 5,200 in the state to 10,000, using pharmacies, police headquarters, schools and the drive-thru system.
Doria further stated that “every Brazilian who is in São Paulo can be immunized, they will not need to prove residence.” “São Paulo is part of Brazil, we can’t turn our backs on any Brazilian,” he said. This raised concern that there would be a race, where people from other states come to be immunized here – vaccination tourism.
According to the governor, “eight states and several city halls [among them Rio de Janeiro and Curitiba] have already ordered the Coronavac from Butantan, and should be provided with four million doses.”
But it is not all that simple. There are specific rules for vaccines to be included in the national SUS network. In any case, Doria’s initiative, and the nod to other states, should it materialize, could assist the governor’s aspirations in 2022, assuming he disputes the presidency.
This is the background of the governor’s political dispute with Jair Bolsonaro over the vaccine. The President has often criticized what he has referred to as the “Chinese vaccine” – the governor refers to it as “the vaccine of Brazil”. During the most acute stage of this vaccine spat, even Minister of Health Eduardo Pazzuelo was targeted. In October he signed a commitment to purchase 46 million doses of the Coronavac, and said it would be included in the National Immunization Program.
Hours later he was rebutted by Bolsonaro on social media: “João Doria’s Chinese vaccine, any vaccine before being made available to the population, must be scientifically confirmed by the Ministry of Health and certified by ANVISA. The Brazilian people will not be anyone’s guinea pigs. My decision is not to acquire this vaccine.”
In fact, so far there is no prospect of including the Coronavac in the national vaccination calendar, but there is growing pressure from state Health Secretaries for this to be accomplished. “What we had were negotiations [with the Ministry of Health], with no formal agreement for the acquisition of the Coronavac for the national immunization program,” said Jean Gorinchteyn, state Secretary of Health.
Amid the controversy, Doria’s initiative has suffered a setback abroad. Sinovac Biotech found itself involved in a recent bribery scandal. A report in The Washington Post earlier this month pointed out that Yin Weidong, then manager of the pharmaceutical company, paid US$83,000 in kickbacks to the Chinese regulatory agency in order to expedite the release of drugs – in the period of payouts, between 2002 and 2011, the company secured registration for such vaccines as the H1N1 flu and hepatitis.
The Federal Government’s plan
While Doria is speeding up, the federal government plan provides for the administration of “immunizers already guaranteed by the Ministry of Health – Fiocruz/AstraZeneca and through the Covax Facility alliance” as of March, according to Health Monitoring Secretary Arnaldo Medeiros. Pfizer’s vaccine would theoretically be excluded from the program because of storage challenges: doses must be stored in a refrigerated environment below -70°C.
The federal schedule provides that the first to be immunized will be healthcare workers; the elderly over 75 or people over 60 living in nursing homes; and the indigenous population. The next priority group will be people aged between 60 and 74, and then people with comorbidities (chronic renal and cardiovascular diseases). The final stage includes teachers, security and rescue forces, prison staff and people deprived of their freedom, and later the general population that has not been contemplated.
The federal government’s schedule to start a national program in March has been criticized by Doria’s office. “We are all perplexed by the Ministry of Health’s plan to begin immunization only in March. In January there will be thousands of sick people, who will be hospitalized, who will die,” said João Gabbardo, executive coordinator of the Coronavirus Contingency Center in São Paulo and ex-secretary of the Ministry. The end-of-year celebrations are expected to increase contagion dramatically in the coming weeks.
But not all believe that it is possible to expedite the federal schedule. Wanderson de Oliveira, ex-secretary of the Ministry of Health’s Epidemiological Surveillance, who stood out during the administration of ex-Minister of Health Luiz Henrique Mandetta, is pessimistic about the proposed deadlines. “A large immunization campaign is not possible in Brazil from the first semester,” he stated in an interview. He believes in a “robust” program only after May or June.
Source: El Pais