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After the announcement that Pfizer and BioNTech vaccine against Covid-19, a BNT162b2, Is more than 90% effective in preventing disease, the coordinator of studies in Brazil, Dr. Edson Moreira, informed that the pharmacist must send the data for the registration of the vaccine in November, along with an emergency use order.
“Pfizer intends to do this [pedido de registro] until the end of that month, until the third week. And, given the seriousness of the matter and the importance of public health, also request approval for emergency use and distribution, ”Moreira told Globo News.
Regarding the effectiveness of 90% of the vaccine developed by Pfizer, Moreira explained that, in addition to having exceeded the expectations of the developers, another important result was registered: the volunteers who took the immunizer had a production of antibodies higher than that of people who had Covid. .
“The 90% effectiveness is extraordinary,” Moreira said. “It may seem like little, but in the world of vaccines, that is the highest response we could hope for.”
The effectiveness rate represents how many people received the vaccine and no to get sick. If that rate is 90%, it means that, among vaccinated people, 90 out of 100 (or 9 out of 10) no got sick, that is, the vaccine could protect them.
BioNTech Director Ugur Sahin said he hoped that the immunity generated by the vaccine lasts at least one year. “We must be optimistic that the effect of immunization can last at least a year,” he said.
Key advertising points
- Pfizer analyzed the data after 94 participants had Covid-19.
- The company did NOT report how many of those 94 people had received the experimental vaccine and how many received the placebo (an inactive substance).
- Initial protection rate may change when the study ends.
- To confirm the effectiveness rate, the company said it will continue the study until there are 164 cases of Covid-19 among the participants. The Pfizer president said this could happen until December, due to high infection rates in the United States.
- Are already 43,538 participants in vaccine trials, distributed between the United States, Brazil and 4 other countries. Of these, 38,955 had already received a second dose vaccine until November 8.
- The data announced by the pharmaceutical company have not yet been reviewed by other scientists, a step that is necessary for them to be published in a scientific journal. Pfizer said these steps will occur as soon as all study results are available.
- According to the Associated Press, participants were evaluated only if they had symptoms. This means that it is not possible to know, for example, if someone vaccinated became infected and did not have symptoms.
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.
Bruce Aylward, deputy director general of the World Health Organization (WHO), said the interim results announced by Pfizer were “very positive.”
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In a social network, the director general of the WHO, Tedros Adhanom Ghebreyesus, also said that the news was encouraging and congratulated scientists around the world.
“We appreciate the encouraging news about the vaccine from Pfizer / BioNTech and also from all the scientists and partners around the world who are developing safe and effective new tools to defeat Covid-19. The world is experiencing unprecedented scientific innovations and collaborations to end the pandemic! ”
The FDA, the United States regulatory agency, has already announced that any vaccine must demonstrate 50% efficacy prior to launch.
Additionally, companies that test vaccines must screen half of their participants for side effects for at least two months, the period of time in which problems usually appear. Pfizer expects to reach that milestone later this month. According to the pharmaceutical company, There have been no serious cases of Covid-19 among the participants so far.
The US regulatory agency also requires that vaccine candidates in the country be tested 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.
