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Friday, 20 August 2021

Azerbaijan trial studying effects of combined Sputnik and AstraZeneca vaccines reports positive results

The Russian Direct Investment Fund (RDIF) has announced the results of a small clinical study that was conducted in the Republic of Azerbaijan. The results from a trial that looked at how AstraZeneca and Sputnik Light doses reacted when combined.

And the results are preliminary but positive.

This could take us one step closer to the idea that mixing two vaccines may be possible and safe.

The study uses the first component of the Sputnik V vaccine (aka Sputnik Light). Sputnik V is a two-dose vaccine made from recombinant adenovirus 26 (Ad26) and adenovirus 5 (Ad5) (Common cold-causing viruses). The first dose (Ad26) is the primary vaccine and the second (Ad5) is the booster shot. The Sputnik Light vaccine is made from Ad26, which is the first part of the Sputnik V vaccine.

Twenty-eight days after vaccination, the Sputnik Light vaccine was 79.4 percent effective against the virus. According to a statement released by the RDIF, the efficacy rate is based on data from Russia’s vaccination program, which ran from 5 December, 2020, to 15 April, 2021.

“Vaccine cocktail" or heterogenous boosting approach, reports News18, was the foundation of Sputnik V. and this approach has succeeded in creating better immunity against the virus.

The AstraZeneca vaccine was developed in cooperation with Oxford University, and is 63.09 percent effective against the SARS-CoV-2 infection. It also has some effect on the newer variants of the virus. Studies have shown that longer intervals between the two doses (ranging from eight to 12 weeks) are associated with greater vaccine efficacy. It is a weakened version of a common cold virus taken from chimpanzees, which has been modified to look more like coronavirus.

Both vaccines use modified viruses that are harmless and act as a vehicle to carry genetic information that helps the human body build immunity against future infections.

A Memorandum of Intent was signed in December 2020, in the presence of the President of Russia Vladimir Putin, between RDIF, the Gamaleya Center, AstraZeneca and R-Pharm.

The study in Azerbaijan began in February 2021. As many as 64 volunteers have been vaccinated till now and the enrollment of volunteers is still ongoing. Preliminary data from the first 20 participants shows antibodies to the SARS-CoV-2 virus spike protein (S-protein) were elicited in 100 percent of cases. There have been no adverse events or infections after vaccination.

Other clinical trials for the combined vaccines are being carried out in UAE and Argentina, while regulatory approval to conduct trials has been granted in Russia and Belarus.

Reuters reports state five Russian clinics will hold trials that will be completed in early March next year, according to the state drug register.

“More trials of Sputnik Light with other producers are also underway in different countries in order to increase the efficacy of other vaccines,” Sputnik V’s developers reported on Twitter.

In India, Sputnik V is being manufactured and distributed by Dr Reddy's Laboratory, and other drug manufacturers include Gland Pharma, Hetero Pharma, Stellis Bio and Virchow Biotech.

The Serum Institute of India is in charge of the distribution of the AstraZeneca vaccine, which is being sold under the Covishield name.

When Tech2 contacted the firms for their response to the latest development, both companies refused to comment on the matter at this time.

Combined vaccines trials in India

There are several trials being conducted around the world to understand if mixing vaccines is safe. In India, there have been reports about the Centre looking into studying the effects of mixing shots of two different vaccines. Niti Aayog member VK Paul had said, "It [vaccine mixing] is plausible. But there need to be more studies... Our experts are also continuously studying…Scientifically, there is no problem.”

There is a definite possibility that mixing vaccines could either generate a stronger immunity or more antibodies, said AIIMS chief Dr Randeep Guleria. "This is something that has been looked at in the past - giving one vaccine as the priming shot and another as the booster.”

Serum Institute of India (SII) chairman Dr Cyrus Poonawalla has previously said he is not in favour of administering two different coronavirus vaccines for better efficacy, as it has not been proven in field trials involving thousands of participants.

He said, "I am against the mixing of two different vaccines. There is no need to mix two different vaccines...if cocktail vaccines are administered and if the result is not good, then SII may say that another vaccine was not good, vice versa, the other company might say that since you mixed Serum's vaccine, it did not give desired results,"

In India, the Indian Council of Medical Research (ICMR) is conducting a study involving 98 people, 18 of whom had inadvertently received Covishield as the first dose and Covaxin as the second, in Uttar Pradesh. It has shown that combining Covishield and Covaxin vaccines elicited better defence than two doses of the same vaccine. The immunisation with the combined vaccine doses was safe and adverse effects were also found to be similar when compared to the people who received the same vaccine with both doses.



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