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The pharmaceutical company Pfizer announced today that its Covid-19 vaccine, developed in partnership with the German company BioNTech, is 95% safe and effective. This is the final conclusion of the third testing phase. Earlier, ten days ago, companies had released a partial result, which pointed to 90% effectiveness. They will now seek approvals from regulatory agencies and must develop logistics solutions. In Brazil there is still no agreement to buy this vaccine, but the Ministry of Health met yesterday with Pfizer.
According to a press release from Pfizer, the vaccine prevents the mildest and most severe forms of COVID-19. And it maintained practically the same efficacy rate for the elderly, reaching 94%, important data considering that it is a public that does not always have efficient reactions to immunizers.
The third phase of the Pfizer / BioNTech vaccine involved about 44,000 volunteers, of whom only half received a vaccine. The other half received a placebo injection, as is standard at this stage. When 170 volunteers had covid-19, the study opened and revealed that 162 of those people had not been vaccinated, only the placebo. The vast majority of those vaccinated were free of covid-19.
Pfizer and BioNTech said the vaccine’s efficacy was consistent across all ages, races, and ethnicities. The most common serious adverse event was fatigue, and 3.7% of the volunteers reported fatigue after taking the second dose of the vaccine.
Next steps
The next step for companies is to apply for an emergency clearance from the United States Food and Drug Administration (FDA). Pfizer said it will be done “in a few days.”
If all the information from Pfizer is confirmed, the development of the vaccine will break all speed records, as it is a process that generally takes years.
“The results of the study mark an important step in this historic eight-month journey to present a vaccine that could help end this devastating pandemic,” said Dr. Albert Bourla, CEO of Pfizer, in a statement.
Pfizer also announced that it could have up to 50 million doses available by the end of the year. And it could produce as much as 1.3 billion by the end of next year.
Difficulties
The Pfizer vaccine has a characteristic that creates logistical difficulties: it must be stored at -70ºC. This is because the vaccine was made with a new technology, using RNA molecules, while other common immunizers use DNA.
The Brazilian Jarbas Barbosa, deputy director of Opas (Pan American Health Organization), recently said that no country in the world is prepared for a vaccination campaign with the immunizer Pfizer.
The pharmaceutical company has said it will ship the vaccine in special boxes filled with dry ice and equipped with GPS-enabled sensors. It can be stored in conventional freezers for up to five days or in special refrigerators for up to 15 days, provided dry ice is replenished and boxes are not opened more than twice a day.
Is it in Brazil?
Some countries, such as the United States, England, Canada and Japan, already have guaranteed doses of the Pfizer vaccine. But for now there is no agreement with Brazil.
The government says it is negotiating with several companies, including Pfizer. The Health Ministry said it met yesterday with a team from the pharmaceutical company.
According to Agência Brasil, the meeting was “technical”, for the laboratory representatives to present the progress of the investigation and for the purchasing, logistics and storage conditions to be evaluated. The folder did not elaborate on the conclusion of the meeting.
Other vaccines
Recently, other partial effectiveness results have appeared. The American company Moderna said that, for now, its vaccine is 94% effective. The Russian “Sputnik V” vaccine said it was 92.5% effective. The CoronaVac vaccine, produced in association with the Butantan Institute, has not yet shown partial results of effectiveness, but it is also in the third phase of testing.
Brazil has already expressed interest in purchasing Moderna’s vaccine. In addition, the country’s participation in Covax (Global Vaccine Access Fund for covid-19) should facilitate this access.
In São Paulo, Governor João Doria bought doses of the CoronaVac vaccine and intends to apply them if he obtains authorization from Anvisa (National Health Surveillance Agency). A portion of them, 120 thousand doses, will arrive in Brazil the day after tomorrow.
But President Jair Bolsonaro (no party) has said he is against buying this vaccine. The São Paulo government has said that it will try to maintain a dialogue to place it in the PNI (National Immunization Plan). But if that doesn’t work, Doria will seek the support of the STF (Supreme Federal Court) to vaccinate the population of São Paulo.
