RIO DE JANEIRO, BRAZIL – The American pharmaceutical company Pfizer and the German laboratory BioNTech said on Wednesday, November 18th, that they proposed the Brazilian government to commercialize the BNT162b2 vaccine against Covid-19.
In the morning, the companies announced the completion of trials and that the immunizer is 95 percent effective.
“Pfizer has made a proposal to the Brazilian government, in line with the agreements that we have closed with other countries – including Latin America, which would allow to vaccinate a few millions of Brazilians in the first semester, subject to regulatory approval,” reported the company in a note.
The company also said that “it will work in partnership with ANVISA (National Health Regulatory Agency) to provide all the required data for the evaluation” of the vaccine’s safety.
Brazil has not yet made any agreement to purchase the immunizer, but this week the Brazilian government received Pfizer executives to, according to the Ministry of Health, “learn about the results of ongoing trials and the conditions of purchase, logistics and storage offered by the laboratory.”
Very low temperatures
In addition to stating that it intends to market the immunizer after ANVISA approval, Pfizer also highlighted in a note that it has already outlined strategies to circumvent what has been pointed out as one of the points of concern in relation to the immunizer: the need for its storage at very low temperatures.
“The company has developed a detailed logistic plan with tools to support effective transport, storage and continuous monitoring of the temperature of the potential vaccine against Covid-19. To this end, a special package (in box format) was developed with controlled temperature, easy to carry and handle, which uses dry ice to maintain the recommended storage condition (…) for up to 15 days,” said the company.
Conclusion of phase 3 trials.
The BNT162b2, which is being tested in Brazil, was the first vaccine to have Phase 3 trials completed. The results released by Pfizer showed that the efficacy achieved in preventing the disease reached 95 percent, and there were no serious side effects. The data have not yet been peer reviewed or published in a scientific journal.
According to a company statement, the vaccine studies analyzed 170 confirmed cases of the novel coronavirus. The trials also involved people over 65 and, within this age group, the vaccine proved to be over 94 percent effective.
The efficacy rate represents the proportion of case reductions among the vaccinated group compared to the non-vaccinated group. In practice, if a vaccine is 95 percent effective, it means that an individual has 95 percent less chances of contracting the disease if immunized.
Request for emergency use
The pharmaceutical company pointed out that all the safety data required by the American health agency, the Food and Drug Administration (FDA), for the Emergency Use Authorization were accomplished. As a result, Pfizer reported that it intends to submit the request for emergency use on Friday.
The company has also advised that it intends to produce up to 50 millions doses of the vaccine in 2020 and 1,3 billion doses by the end of 2021.
In July, the United States closed an agreement with the laboratory to buy 100 millions doses this year for US$1.95 billion.
Meeting with Pfizer
The Ministry of Health announced on Tuesday that it met with Pfizer executives, but no purchases of the immunizer were announced by the Brazilian government.
“The goal is to learn about the ongoing trials results and the purchase conditions, logistics and storage offered by the laboratory. The purchase of immunizers should occur as clinical trials demonstrate the total efficacy and safety of raw materials and registration with the National Health Surveillance Agency is accomplished,” said the Ministry of Health.
Three partnerships in Brazil
Currently, Brazil has a partnership for the future production of three vaccine candidates.
ChAdOx1 – The federal government has signed an agreement to purchase the ChAdOx1, developed by AstraZeneca/Oxford, which includes a partnership with the Oswaldo Cruz Foundation to produce the vaccine in Brazil. The federal government will invest R$1.9 billion to produce 100 million doses.
CoronaVac – The São Paulo government has an agreement to buy the CoronaVac, in production by Chinese pharmaceutical company Sinovac, and the Butantan Institute will be a partner in the production of the vaccine. It is expected that the first 120,000 doses of the CoronaVac will reach Brazil on Friday, November 20th. So far, this is the most advanced announcement regarding the arrival of vaccines in Brazil.
Sputnik V – There is also an agreement of the Paraná state government for the Sputnik V vaccine, developed by the Russian Gamaleya Institute.
In addition to these partnerships, the federal government has signed an agreement with the World Health Organization (W.H.O.) to secure 42 million doses of a Covid-19 vaccine within the initiative called Covax Facility. The company supplying the vaccine has not yet been defined. Currently, the W.H.O. is monitoring a portfolio of candidate vaccines. The Brazilian government will invest approximately R$2.5 billion in the agreement.
Source: G1