Health

Doctors say COVID-19 vaccines based on the new platform need to be checked after Phase 3 trials

Moscow (Sputnik)-COVID-19 vaccine, which uses a new platform to elicit an immune response, needs to be studied for its potential long-term effects, even if it passes Phase 3 trials, anesthesiology and Professor Sergei Zalenko, Deputy Doctor of Resuscitation, said the 52nd Hospital in Moscow.

“We believe that new vaccines based on the new platform will need to be checked for long-term effects, even after completing Phase 3 trials,” said the US Food and Drug Administration (FDA). Tsarenko said when expanding the probe to the AstraZeneca vaccine.

The professor emphasized the risks associated with this vaccine development method, based on recent incidents.

“The annual incidence of transverse myelitis ranges from 1.34 to 4.60 per million. The likelihood of two cases of transverse myelitis in the AstraZeneca trial is 1 in 22,000 (0.00495%). Less than, “Tsarenko emphasized. The Russian Sputnik V vaccine was developed on a proven human adenovirus platform.

Testing is currently being resumed in the UK and other countries, but the United States has not yet given a go-ahead to resume testing.

Early in the day Reuters News agency quoted sources to expand the FDA’s investigation into possible negative side effects of the vaccine after the UK trial was suspended at the beginning of the month because participants developed a neurological syndrome. Reported. Later, another volunteer became ill with transverse myelitis, a neuropathy caused by inflammation of part of the spinal cord.

Developed by Sputnik V, Institute of Epidemiology and MicrobiologyWas registered by the Russian Ministry of Health on August 11th and became the first registered vaccine against COVID-19 in the world. It is currently in Phase 3 testing.

The AstraZeneca vaccine, which uses a chimpanzee adenovirus-based vector, is being developed in collaboration with the Jenner Institute at Oxford University and the Oxford Vaccine Group and is in Phase 3 trials, the final step before safety and efficacy data are available. .. Submit to health regulator Seeking approval.

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