Pfizer Says It Made A Proposal To The Government That Would Allow ‘To Vaccinate Some Million Brazilians In The First Half’ Against Covid | Vaccine

In the morning, the companies announced the completion of the tests and that the immunizer is 95% effective.

“Pfizer made a proposal to the Brazilian government, in line with the agreements we have signed in other countries, including in Latin America, that would allow to vaccinate a few million Brazilians in the first half, subject to regulatory approval,” the company said in a note.

• Pfizer and BioNTech vaccine against Covid completes phase 3 studies and announces 95% effectiveness
• Anvisa approves measures to accelerate the registration of the vaccine against Covid-19 in Brazil

The company also said that it “will work in partnership with Anvisa (National Health Surveillance Agency) to provide all the data necessary for the evaluation” of the safety of the vaccine.

Brazil has not yet reached an agreement to acquire the immunizer, but this week the Brazilian government received executives from Pfizer to, according to the Ministry of Health, “to know the results of the ongoing tests and the purchasing, logistics and storage conditions that offers the laboratory. ” . (Read more at the end of the story)

Very low temperatures

In addition to stating that it intends to commercialize the immunizer after the approval of Anvisa, the company also highlighted in a note that it has already outlined strategies to circumvent what was pointed out with one of the points of attention in relation to the immunizer: the need for conservation at extremely low temperatures .

“The company developed a detailed logistics plan with tools to support the effective transportation, storage and continuous monitoring of the temperature of the possible vaccine against Covid-19. For this, a special temperature-controlled packaging (in box format) was developed, easy to transport and handle, which uses dry ice to maintain the recommended storage conditions (…) for up to 15 days, ”said the company.

Completion of phase 3 tests

BNT162b2, which is being tested in Brazil, was the first vaccine to complete phase 3 trials. The results showed that the effectiveness achieved was 95% in disease prevention and there were no serious side effects.. The data has not yet been published in a scientific journal.

According to a statement from Pfizer, the vaccine studies looked at 170 confirmed cases of the new coronavirus. The tests also involved people over 65 years of age, and of this age group, the vaccine was shown to be more than 94% effective.

The efficacy rate represents the proportion of reduction in cases among the vaccinated group compared to the unvaccinated group. In practice, if a vaccine is 95% effective, it means that the person is 95% less likely to contract the disease if they are vaccinated than if they are not.

The pharmacist pointed out that all the safety data required by the US health agency, the Food and Drug Administration (FDA), for the Emergency Use Authorization have been achieved. With that, Pfizer said it intends to request the emergency use of its vaccine “in a few days”, without giving a specific date.

The company also said it plans to produce up to 50 million doses of vaccine globally in 2020 and 1.3 billion doses by the end of 2021.

In July, the United States signed an agreement with laboratories to buy 100 million doses later this year for $ 1.95 billion.

Key advertising points

• Pfizer analyzed the data after 170 participants had Covid-19
• Of these 170 people, 8 received the experimental vaccine and 162 received placebo (an inactive substance)
• The tests involved 43,661 volunteers distributed among the United States, Brazil, Argentina, Germany, Turkey and South Africa.
• The effectiveness observed in adults between 65 and 85 years old was greater than 94%
• Efficacy begins 28 days after administration of the first vaccine.
• Among the side effects, 3.8% had fatigue and 2% had a headache.
• The data that the pharmaceutical company announced has not yet been published in a scientific journal
• The Pfizer vaccine is given in two doses.

Brazil welcomed Pfizer executives

The Ministry of Health reported on Tuesday (17) that it received executives from Pfizer, but the purchases of the immunizer by the Brazilian government were not announced.

“The objective is to know the results of the tests in progress and the purchasing, logistics and storage conditions offered by the laboratory. The acquisition of immunizers should occur since the clinical trials aim at the total effectiveness and safety of the supplies and the registration in the Agency. National Sanitary Surveillance (Anvisa) is carried out ”- Ministry of Health.

Currently, two candidate vaccines are being developed in the country: AstraZeneca / Oxford, in association with the Oswaldo Cruz Foundation, and Sinovac, in association with the Butantan Institute. There is also an agreement from the Paraná government with the Sputnik V vaccine, from the Gamaleya Institute, in Russia.

In October, the Ministry of Health announced the purchase of 46 million doses of the Chinese CoronaVac vaccine. The next day, President Jair Bolsonaro denied that the government bought the doses on a social network: “We will not buy the vaccine from China.” The executive secretary of the Ministry, Elcio Franco, reiterated hours later the president’s statement: “There is no intention to buy Chinese vaccines.”

On November 9, the governor of São Paulo, João Doria, announced that the state will receive the first 120,000 doses of CoronaVac, developed by Sinovac with the Butantan Institute, on Friday, November 20. So far, this is the most advanced announcement about the arrival of vaccines in Brazil.

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