Sputnik V, the world’s first officially registered Covid-19 vaccine – telam

The drug uses non-living particles created from adenoviruses.

Sputnik V was established on August 11 as the world’s first officially registered coronavirus vaccine by a government, after six months of a pandemic and, according to results published in the British medical journal “The Lancet”, the product generates antibodies and does not does not cause unwanted incidents.

A few days after the announcement, the first batch of vaccine exceeded 15,000 doses and was distributed on a trial basis in different parts of this country.

The expert group found that two formulations – one frozen and one freeze-dried – of a two-part vaccine are “safe” because they did not identify serious adverse reactions in more than 42 days, and they caused antibody responses in all participants. within 21 days.

Secondary results from the trials – not as relevant as the main ones – showed, scientists say, that vaccines produce the so-called T cell response within 28 days, which detects and kills invading pathogens or cells. infected.

The drug uses non-living particles created from adenoviruses, said Alexander Guíntsburg, director of the National Research Center in Gamaleya, the body behind the vaccine.

“Living particles are those that can reproduce. The particles used do not have this function,” Guíntsburg said in a broadcast on Rossiya channel 24.

Thus, the coronavirus particles contained in the vaccine cannot harm the body, Guíntsburg pointed out.

According to the scientist, the coronavirus particles can cause discomfort, because when a foreign antigen is injected, the immune system works more actively, and in such cases, the patient may have a fever.

Attempts

In clinical trials of the drug, the temperature of volunteers reached 37 degrees and sometimes 38. But this problem “is solved with paracetamol,” Guíntsburg said.

The trials were carried out in two Russian hospitals with 76 adults between the ages of 18 and 60, who were isolated upon enrollment to participate in clinical trials and remained in medical centers for the first 28 days.

The secondary results of the trials (not as relevant as the main ones) have also led to believe that vaccines produce, within 28 days, the so-called T cell response, which detects and kills pathogens or invading cells. infected.

Among some of the results, they found both formulations to be safe and well tolerated, and the most common adverse factors included pain at the injection site (in 58% of participants), hyperthermia (in 50%), headache (42%), asthenia (28%) and muscle and joint pain (24%).

Towards mass production

On October 9, the Russian Direct Investment Foundation (FIDR) and Mexican pharmaceutical company Landsteiner Scientific signed an agreement to supply Mexico with a total of 32 million doses, which will supply 25% of the Mexican population.

On October 27, Russia submitted to the World Health Organization (WHO) an application for accelerated registration and prequalification of the vaccine, “which will allow Sputnik V to be included in the list of drugs meeting major standards. of quality, safety and efficiency, ”reported the Russian Direct Investment Fund (RDIF).

If Sputnik V meets the conditions of quality, safety and efficacy established by the WHO, its authorization will allow the Russian vaccine to be accessible to all within a shorter timeframe compared to conventional procedures.

Currently, Sputnik V is in the post-registration phase with the participation of 40,000 volunteers in Russia.