Moderna claims its vaccine is 94.5% effective, according to preliminary phase 3 analysis | Vaccine

The efficacy rate represents the proportion of case reduction among the vaccinated group compared to the unvaccinated group.

In practice, if a vaccine is 90% effective, it means that the person is 90% less likely to contract the disease if they are vaccinated than if they are not.

• See which vaccines are being tested in humans around the world

Moderna’s provisional analysis included 95 trial participants who received a placebo or a vaccine. Of these, only five infections occurred in those who received the vaccine, which is given in two doses 28 days apart.

“This is a crucial moment in the development of our candidate vaccine. Since the beginning of January, we have been pursuing this virus with the intention of protecting as many people as possible around the world. We know that every day is important. This positive interim analysis from our phase 3 study gave us the first clinical validation that our vaccine can prevent against disease, including severe cases, ”said Sne Bancetéphal, CEO of Moderna.

Based on these interim safety and efficacy data, Moderna intends to apply to the Food and Drug Administration (US regulatory body equivalent to Anvisa) for authorization for the emergency use of the vaccine in the coming weeks. The drugmaker also plans to submit authorization requests to global regulatory agencies.

See the main points of the announcement:

• The first analysis included 95 participants with confirmed cases of Covid-19.
• There is more than 30,000 participants in vaccine trials – half received a placebo and the other half received the vaccine. Over the months, 90 volunteers who received placebo developed severe forms of Covid-19. Among the participants who received the vaccine, five developed the coronavirus, but none became seriously ill. This result points to an effectiveness of 94.5%.
• The data has not been published in any scientific journal and are subject to change.
• The vaccine is applied in two doses. Efficacy results were calculated from two weeks after the application of the second dose.
• According to the pharmaceutical company, an adverse event study indicated that The vaccine was well tolerated, without major safety concerns.. The effects were mild or moderate.
• Based on the interim analysis, Moderna intends to request that the FDA emergency use of the vaccine In the next weeks.

Other candidate vaccines also presented preliminary efficacy data last week. However, no analysis has yet been published in a scientific journal..

On November 9, the pharmaceutical companies Pfizer and BioNTech announced that their candidate for the Covid-19 vaccine, the BNT162b2, that is being tested in Brazil, is more than 90% effective in preventing disease.

On November 11, Russia said the vaccine Sputnik V, developed by the Gamaleya Institute against Covid-19, is 92% effective, according to preliminary data from phase 3 studies conducted in the country.

The FDA, the US regulatory agency equivalent to Anvisa in Brazil, has already announced that any vaccine must demonstrate 50% effectiveness before being released in the United States.

Additionally, companies that test vaccines must screen half of their participants for side effects for at least two months, the period of time when problems typically appear.

The US regulatory agency also requires that vaccine candidates in the country be screened 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.

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 in animals, usually mice and then monkeys.

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