Pfizer and BioNTech Covid Vaccine Completes Phase 3 Studies and Announces 95% Effectiveness | Vaccine

According to a statement from Pfizer, the vaccine studies looked at 170 confirmed cases of 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, this 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.

See the main points of the announcement:

• 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)
• 43.66i 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 that the pharmaceutical company announced has not yet been published in a scientific journal
• The Pfizer vaccine is given in two doses.

The Pfizer and BioNTech vaccine is the first to announce 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 received executives from Pfizer.

“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, ”the folder reported.

Immunity can last for a year

On the 9th, BioNTech Director Ugur Sahin said that he hoped that the immunity generated by the vaccine lasts at least one 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% efficacy before it is launched.

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 studied in at least 30,000 people. Studies should include, in addition to older adults, other risk groups, such as minorities and people with chronic health problems.

How the 3 phases work

When testing a vaccine, usually divided into phases 1, 2 and 3, scientists try to identify serious adverse effects and whether the immunization was able to induce an immune response, that is, a response from the body’s defense system.

• Why Phase 3 Clinical Trials Are Essential to Your Success and Safety

Phase 1 trials generally involve dozens of volunteers; those of phase 2, hundreds; and phase 3, thousands. These phases are generally carried out separately, but due to the urgency of finding an immunization for Covid-19, several companies have taken more than one step at the same time.

• The four types of vaccines against Covid-19 and what remains to be ready

Before testing in humans, vaccines are tested on animals, usually mice and then monkeys.

VIDEOS: see news about vaccines against Covid-19