UK approves Pfizer and Biontech vaccine and announces that it will start to be applied next week | Vaccine

British Health Minister Matt Hancock said the local regulatory agency had approved the Pfizer vaccine.

“Early next week, we will start a vaccination program for people against Covid-19 here in this country,” he told Sky News. Consider the “fantastic” news.

Pharmaceuticals Pfizer and BioNTech announced in early November that their Covid-19 vaccine candidate, BNT162b2, which is being tested in Brazil, is more than 90% effective in preventing the disease, according to initial data from the phase 3 study. they have not yet been published in a scientific journal.

The results showed that the effectiveness achieved was 95% in preventing the disease and there were no serious side effects. The data has not yet been published in a scientific journal.

• Anvisa approves measures to accelerate the registration of the vaccine against Covid-19 in Brazil

Brazil has not yet reached an agreement to acquire the vaccine, 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 purchase, logistics and storage conditions that offers the laboratory. ” . (Read more at the end of the report)

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 effectiveness rate represents the proportion of case reduction 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.

• 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)
• 43,661 volunteers distributed among the United States, Brazil, Argentina, Germany, Turkey and South Africa participated in the tests.
• 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 announced by the pharmaceutical company has not yet been published in a scientific journal
• The Pfizer vaccine is given in two doses.

The government received executives from Pfizer

The Pfizer and BioNTech vaccine is the first to have an announcement of the completion of testing in phase 3, the last stage of vaccine development.

In Brazil, the Ministry of Health reported on Tuesday (17) that it had received executives from Pfizer, but the purchases of the immunizer by the Brazilian government have not yet been 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. The National Sanitary Surveillance Agency (Anvisa) is being carried out ”, reported the Health folder.

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 between the government of Paraná and 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 to Brazil.

Immunity can last a year

On the 9th, BioNTech director Ugur Sahin said he expected the immunity generated by the vaccine to last at least a year. “We must be more optimistic that the effect of immunization can last at least a year,” he said.

“This is excellent news. 90% is an extraordinary number. Other vaccines that we use today are in the range of 60, 70%,” evaluated Dr. Edson Moreira, who coordinates the vaccine studies in Brazil.

“The question is the duration [da proteção] and the eventual need for reinforcement or not, but they are different things ”, Moreira completed.

Pfizer and BioNTech also said that, so far, they have found no serious safety issues and hope to obtain an emergency use authorization in the US later this month.

The FDA, the United States regulatory agency, has already announced that any vaccine must demonstrate 50% effectiveness before launch.

Additionally, companies that test vaccines must screen half of their participants for side effects for at least two months, the period of time during which problems typically appear. Pfizer expects to reach that milestone later this month. According to the pharmacist, so far there have been no serious cases of Covid-19 among the participants.

The US regulatory agency also requires that vaccine candidates in the country be studied in at least 30,000 people. Studies must include, in addition to older adults, other risk groups, such as minorities and people with chronic health problems.