Russia Says Covid-19 Vaccine Was ‘More Than 95%’ Effective After Second Dose | Vaccine

See the main points of the announcement:

• The efficacy of the vaccine was “greater than 95%” 21 days after the second dose of the vaccine (42 days after the first dose).
• Before that, 7 days after applying the second dose (and 28 days after the first dose), the observed effectiveness was 91.4%.
• In total, the analysis considers data from 18,794 vaccinated people.. Of these, 14,095 received the vaccine, in both doses. The other 4,699 received an inactive substance (placebo).
• Among those vaccinated, there were 8 cases of Covid-19 seven days after the second dose (and 28 days after the first dose). Among the unvaccinated, there were 31 cases in the same period. The figures are equivalent to 91.4% effectiveness. Detailed figures for efficacy greater than 95% have not been published.
• Until this Tuesday (24), no unexpected adverse events have been identified. Some of those vaccinated experienced minor short-term adverse events, such as injection site pain and flu-like symptoms such as fever, weakness, fatigue, and headache.
• The Russian production capacity is one billion doses, enough for 500 million people (with two doses each).
• Like Oxford vaccine, the storage temperature of Sputnik V is 2 ° C to 8 ° C (normal refrigeration conditions). It is an advantage over the Pfizer candidate, which must be stored at -70ºC during transport, and Moderna, which must be kept at -20ºC.

About two weeks ago, Russia had announced a 92% effectiveness for Sputnik V one day after the application of the second dose (and 21 days after the application of the first).

In practice, if a vaccine is more than 95% effective, this means that more than 95% of the people who receive the vaccine are protected against that disease.

The announcement about the effectiveness of Sputnik V was made in another day when Russia surpassed a daily record number of Covid-19 cases: 24,326 new infections in 24 hours, announced the coronavirus crisis center on Tuesday (24), according to the state news agency Tass. It is the fifth consecutive day that the number of new cases in the country exceeds 24 thousand.

In total, the country has registered 2,138,828 cases since the start of the pandemic and 37,031 deaths, the fifth highest number in Europe.

Russia was the first country to register a Covid-19 vaccine in the world, in August. The announcement raised concern among scientists, among other reasons, over the announcement of phase 3 trials and simultaneous mass vaccination (see details on the testing phases of a vaccine below).

In October, the country applied for approval for emergency use of Sputnik V from the World Health Organization (WHO).

The Russian government also partnered with the Paraná government to produce Sputnik V on Brazilian soil. Last month, the Russian fund that finances the development of the vaccine announced that Brazil could start producing it in December.

Russia also announced its second vaccine candidate in October. Mass vaccination of the Russian population with the second vaccine is scheduled for next year, according to Tass.

In recent weeks, laboratories such as Pfizer, Moderna and AstraZeneca, which develops a vaccine in partnership with Oxford, published the results of the initial phase 3 on the effectiveness rate of their vaccines still in development. Neither has yet published a scientific study with the data.

Initial data released by the companies indicated the following efficacy rates for their vaccines in development; rates may still change:

The FDA, the US regulatory agency equivalent to Anvisa in Brazil, has already announced that Any vaccine must demonstrate 50% efficacy before it is released in the US.

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.

• STAGES: Why Phase 3 Clinical Trials Are Essential to Vaccine Safety and Success

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.

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

VIDEOS: see news about vaccines against Covid-19