RIO DE JANEIRO, BRAZIL – Minister of Health Eduardo Pazuello estimates that the vaccination campaign against Covid-19 in Brazil may kick off in mid-February, if laboratories apply for definitive registration with health regulator ANVISA still in December.
“Possibly from mid-February onwards we will have received and registered vaccines to begin the plan,” he said during a ceremony on Wednesday, December 16th, for the official launch of the National Immunization Plan. However, a final date will only be known once the agency authorizes an immunizer, and the campaign to immunize the whole population is expected to take 16 months.
The Butantan Institute – linked to the São Paulo Government and which has an agreement to produce the Chinese Sinovac laboratory vaccine in Brazil – signaled that it would apply for the final registration on December 23rd. After pressure from governors, the Ministry of Health included the immunizer – which is at the heart of a political feud between President Jair Bolsonaro and São Paulo Governor João Doria – in the plan.
For now, the plan details the logistic planning exclusively for the Pfizer vaccine, aiming to immunize 11% of healthcare professionals in capitals and metropolitan cities in a first stage. The government says it has agreements to acquire 350 million doses from different laboratories, but the plan’s delivery schedule is still vague.
A target of criticism from its own technical staff who took part in its discussion in recent days, the plan includes demands from the technical chamber to incorporate the Chinese Sinovac laboratory vaccine and to add quilombola communities, people in detention and riverside communities in priority groups, but still leaves a number of questions open. When these groups will be included in the campaign or their population size has not yet been defined.
Many details on the logistic operation of the 15 vaccines mentioned as likely to join the Brazilian campaign are also lacking – nine of them are from the global Covax Facility consortium. With the exception of Pfizer, the Ministry says in the official document that the logistic schedule of vaccines depends on the companies’ “feedback on the quantity of available doses and delivery schedule”.
The Ministry expects the delivery of two million Pfizer doses by March and proposes to concentrate them in capitals and metropolitan regions, as the immunizer needs deep-freezers to be stored at -70 ºC. This amount is expected to immunize 626,000 healthcare professionals who worked at the frontline of the pandemic this year – 11% of the total number of workers expected in the first priority group.
“The surplus is directed to other healthcare professionals. The Government also estimates 10% of doses for potential problems of loss due to the vaccine’s features,” points out the document. However, the plan does not establish the equipment to be acquired for this strategy, while pointing out that the lowest temperature sustained by the SUS (National Health System) cooling network is -30ºC.
The plan also fails to directly mention an agreement with Moderna, another promising vaccine which is close to securing authorization from international agencies. The vaccine is part of the Covax consortium, but World Health Organization internal documents point out that the facility runs a “very high” risk of failing for lack of funding, which could result in nations of billions of people being denied access to vaccines until the end of 2024, according to a Reuters report.
The Ministry of Health states that there is a “guarantee” of about 350 million doses from Covax, Pfizer and AstraZeneca agreements. The latter concentrates most of the expected doses and has a technology transfer agreement with Fiocruz, which has already announced it will apply for final registration -not emergency-, with no dates specified. The schedule includes the production of 30 million doses by February.
Researchers have expressed concern over the lack of assertive estimates on the supply of different vaccines, but see as positive the intention to purchase all vaccines authorized by ANVISA. The Government’s plan points out that at least 70% of the population would need to be immunized to contain the novel coronavirus.
The Ministry of Health says it intends to purchase vaccines for the entire population. A Provisional Measure to be announced in coming days should include R$20 billion for the purchase of immunizers. But, as Brazil has been lagging behind in negotiations, doubt remains as to when there will be a significant amount of vaccines available in the country. Minister Pazuello says that, at the moment, there aren’t enough doses produced in Brazil to begin a vaccination campaign.
“We need to produce more and be able to control anxiety and distress. The next 45 days will be critical to complete the processes,” he said.
Pazuello assured that the country will buy “all the registered and produced vaccines that are safe”, during a press conference on Wednesday. The Minister also said that only the immunizers registered by ANVISA will be used in a mass vaccination campaign. “No vaccine lacking ANVISA registration and approval will be allowed,” he said. Moreover, vaccines granted emergency use approval should be limited to specific groups and administered to volunteers, subject to a signed consent form.
“If a laboratory applies for emergency authorization and ANVISA grants it to that specific group, the people involved will sign a consent form. Only in these cases. Otherwise, not at all,” declared the Minister.
Bolsonaro rehearses change of discourse
The requirement for a consent form was championed by President Jair Bolsonaro this week, but Chamber of Deputies president Rodrigo Maia has already announced that the Provisional Measure to release R$20 billion for the purchase of drugs, which will be voted on Thursday, will exclude any consent form requirement.
“We have already agreed with the [congressional leadership] that the consent form required by the government will not be included in the Vaccine Provisional Measure, which we will vote on Thursday. This issue came from the government, it was never a demand of the Chamber.
– Rodrigo Maia (@RodrigoMaia) December 16th, 2020”
Bolsonaro also declared that he would not be immunized against Covid-19 and said he asked the Ministry of Health to disclose the danger of vaccines. However, the document submitted by the portfolio is against what the President requested and signals a two-phase communication campaign to reassure the population about the vaccines’ efficacy.
Bolsonaro began to change his discourse during the introduction of the national plan. “If any of us overreacted, it was in our quest to find a solution,” he said of the political war being waged over vaccination.
Bolsonaro preached unity, after months criticizing mayors and governors who imposed restrictive measures to reduce infections. The President, who maintained an erratic and denialist stance, now claims that all rulers are seeking “a tangible alternative to get rid of this evil”.