Brazil's National Health Surveillance Agency (Anvisa) Friday approves, albeit with some restrictions, imports of Covaxin and Sputnik V doses for use in up to 1% of the country's population, it was announced.
The country currently uses CoronaVac, AstraZeneca/Oxford, Pfizer/BioNTech and Janssen immunizers. The new decision applies only to specific batches.
In the case of Covaxin, the authorization defined the amount of 4 million doses, which can only be used under specific conditions determined by the Agency.
As for Sputnik, the number of doses will be restricted to 1% of the population of each of the six requesting states: Bahia, Maranhão, Sergipe, Ceará, Pernambuco and Piauí.
The agency, which had recently rejected the purchase of immunizers, changed its viewpoint after the arrival of new documents from manufacturers, although it established additional protocols for the application of doses and limiting the number of people who can be vaccinated.
In April, an application for authorization to import 30 million doses of the Sputnik V vaccine, developed by Russia's Gamaleya Institute, to 14 states had been rejected by Anvisa.
The import request by the states is distinct and independent from the request for emergency use of Sputnik V made by the company União Química. União Química's request has a suspended analysis period and depends on complete information from the laboratory. Until now, it has authorization for bottling the vaccine in Brazil, but not for manufacturing.
Covaxin, manufactured by Indian company Bharat Biotech, was ordered by the Ministry of Health. The ministry renewed its import order for 20 million doses after a first purchase request was denied by the agency in March.
Due to technical uncertainties present in the documentation of the Sputnik V and Covaxin vaccines, Anvisa decided to approve the import but provided that protocols for the controlled use of immunizing agents are followed.
Among other points, the conditions for importing the two vaccines are: Immediate suspension of applications if Anvisa or the World Health Organization (WHO) disapprove of the emergency use of the vaccine in question; non-use of vaccines in people with hypersensitivity to any of the components of the formula, pregnancy, nursing mothers, people under 18 or over 60 years of age, women of childbearing age who wish to become pregnant in the next 12 months, serious or uncontrolled illnesses and a history of anaphylaxis; prohibition of application in people who have received another vaccine against covid-19, with fever, HIV, hepatitis B or C, who have been vaccinated in the previous 4 weeks, who have received immunoglobulins or blood products 3 months before, who have received treatments with immunosuppressants, cytotoxics, chemotherapy or radiation 36 months, have received biologic therapies including anti-cytokine antibodies and other antibodies; import of doses manufactured in plants inspected by Anvisa; imported lots must be approved by Fiocruz's National Institute for Quality Control in Health (INCQS); package inserts and labels must be made available in Portuguese; clear identification that the immunizing agent is not evaluated by Anvisa regarding quality, efficacy and safety criteria. And once the list of requirements is met in the case of Sputnik V, a study of the effectiveness of the vaccine will still be required.
According to Anvisa, the Russian authority's report has limited safety data and evidence of risk considering the components of the first and second dose, the case of replicating adenovirus pointed out by Anvisa in April (learn more below). The INCQS or laboratories certified by Anvisa will be responsible for the quality analysis of all batches of Sputnik V and the states were going to be responsible for ensuring the protocols so that there is no change between the first and second doses, in addition to reporting adverse events.
Anvisa also decided that the number of doses of Sputnik will be limited to 1% of the state's population to simplify its control, and apportioned as follows: Bahia: 300,000; Pernambuco: 192,000; Ceará: 183,000; Maranhão: 141,000; Piauí: 66,000; Sergipe: 46,000. After using the aforementioned quantity, Anvisa will evaluate the monitoring data on the use of the vaccine to support the Agency's new deliberation regarding the next quantities to be imported, said the director and reporter at Anvisa Alex Machado Campos.
In the case of Covaxin, Anvisa is awaiting results of immunogenicity and clinical safety report of the vaccine. INCQS will be in charge of the laboratory analysis to demonstrate the potency of the imported vaccine, the antigenic content and quality.
Due to the lack of stability data, Covaxin vials should be used in their entirety immediately. If the manufacturer proves that the doses can be stored for longer, the guidance will be adapted.
In addition, Covaxin will also have limited amounts of doses to 1% of the Brazilian population. According to Anvisa, the idea of requiring these measures and limiting doses is to have a risk management plan for the use of products at the first warning sign.
We are not attesting to the quality, safety and efficacy of these two vaccines, there are technical issues that need to be resolved. We are making an effort, as a technical area, to think of strategies to resolve access to vaccines, says Anvisa's General Manager of Medicines Gustavo Mendes.
We know that vaccines are important, but vaccines of quality, safety and proven efficacy. So, that is why there is a recommendation that this use is controlled, that the results that will be generated be carefully observed, so that people know what exists and what does not exist of these vaccines so that we can be very transparent with whoever will eventually use them, he said.
Anvisa pointed out that, despite the new documentation evaluated raising the range of information to the point of this special authorization, the conditions imposed on the states and the Union are still necessary to monitor the effects of Sputnik V and Covaxin.
Anvisa also explained through its YouTube channel that the aforementioned clearances were temporary. Anvisa board member Alex Machado explained that the amounts authorized would be enough for the initial stage of vaccination after which its results will be submitted to Anvisa for further evaluation.
The proposal was supported by three other members of the five-member board, including Anvisa Director-President Antonio Barra Torres.
Russia’s Sputnik V anti-coronavirus vaccine will be delivered to Brazil in July, Russian Direct Investment Fund (RDIF) head Kirill Dmitriev said through the vaccine’s official Twitter account.
Brazil has become the 67th country to approve the use of Sputnik V. The vaccine is the world’s second most popular in terms of the number of approvals issued by government regulators.
The decision by ANVISA to authorize the import and use of Sputnik V by states in Brazil is a long-awaited event for people in Brazil who will obtain access to one of the best COVID vaccines in the world. While a comprehensive data package had been sent to ANVISA initially, no questions raised by the regulators were left unanswered after it decided to delay the authorization of Sputnik V. The Russian side provided all additional data, Dmitriev added.
With the approval of the vaccine in several states Brazil will become the most populated country of South America to use the Russian vaccine. We are looking forward to furthering effective cooperation with partners in the country to save lives and overcome the pandemic, he went on.