REGULATORY NEWS UPDATE 1

1.Russia says Sputnik Light 93.5% effective in Paraguay vaccination campaign
The Russian Direct Investment Fund (RDIF) on Wednesday, 18th August 2021 announced the data from Paraguay regarding the one-shot Russian Sputnik Light vaccine demonstrating high safety profile and a 93.5% efficacy.
An official release stated that the one-shot Sputnik Light vaccine has proven to be highly effective against COVID-19 among more than 320,000 subjects who had received the vaccine based on the data collected by July 30, 2021.The data also indicates a high safety profile of Sputnik Light with no serious adverse events associated with vaccination.

Also, RDIF, Ministry of Health of Argentina, Ministry of Science of Argentina and CONICET are conducting a study for the evaluation of the immune response and safety of heterogeneous regimens combining Sputnik Light and vaccines produced by AstraZeneca, Sinopharm and Moderna in the city and province of Buenos Aires, as well as San Luis, Cordoba and La Rioja provinces. The results of the study will be published in a peer-reviewed medical journal.

2.Higher risk of Bell's Palsy after Sinovac's COVID-19 vaccine-study
The risk of Bell's Palsy, a type of facial paralysis, is higher after Sinovac Biotech Ltd's SVA.O COVID-19 vaccine, CoronaVac, but should not be a deterrent to vaccination, according to a study published in The Lancet Infectious Diseases Journal.

The study mentioned that the beneficial and protective effects of the inactivated COVID-19 vaccine far outweigh the risk of generally self-limiting adverse event of Bell's Palsy.

The study involved 28 clinically confirmed cases of Bell's Palsy after Sinovac's CoronaVac shot reported among nearly 452,000 individuals who received first dose of the vaccine, and 16 cases after Pfizer/BioNtech's vaccine detected from more than 537,000 individuals.

3.UK review finds COVID-19 shots do not raise risk of miscarriage
The UK's health regulator said on Monday, 16th August 2021 COVID-19 vaccines did not raise the risk of miscarriage, and that it had not found any link between the shots and changes to menstrual periods.

The Medicines and Healthcare products Regulatory Agency (MHRA) stated that there is no pattern from the reports to suggest that any of the COVID-19 vaccines used in the UK increase the risk of miscarriage or stillbirth.

The MHRA's findings are in line with a similar review from Europe earlier this month, which showed no causal link between COVID-19 vaccines and menstrual disorders.

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