Amid delivery delay, 6 countries study combining COVID-19 Sputnik V vaccine with others

 As Russia's Gamaleya Institute was delayed in producing and delivering the second dose, trials are underway to assess whether it can be swapped with different vaccines to complete the schedule. Russia announced the start of studies on the combination with the AstraZeneca dosage. Other such analyzes are already being carried out in Argentina, Azerbaijan, the United Arab Emirates, Belarus and India.

After the delays in the delivery of the second component of the Sputnik V vaccine, Russia agreed to carry out combination studies with different inoculants in England, Azerbaijan, United Arab Emirates, Belarus and Argentina (RDIF) (Handout via REUTERS)

The COVID-19 Sputnik V vaccine was developed by the Gamaleya Institute of the Russian Federation, and became the first licensed in the world. 69 countries have already joined to authorize it for emergency use in their population, in response to the pandemic, and have made dose purchase agreements. It is a vaccine with a non-replicative viral vector, with a schedule of two different doses. Since March, the production and delivery from Russia of the second component has been delayed and today millions of people are anxiously waiting to receive the dose to complete the scheme. Last July 22, there were almost 6.6 million people in Argentina in that situation.

The delay in delivery from Russia prompted health authorities in various countries to initiate clinical trials to study whether the first dose of Sputnik V vaccine can be effectively and safely combined with a dose of a different vaccine.Several of these studies are already in progress. The latest trial to be announced is one that will evaluate the combination of a dose of Sputnik V with the vaccine developed by the University of Oxford with the company AstraZeneca.It will be done in Russia in collaboration with England. There are also studies in India, Azerbaijan, United Arab Emirates, Belarus, and Argentina.

Last May, the ethics committee of the Russian Ministry of Health had suspended the approval process for such clinical trials and had requested additional information. According to the Russian regulatory authority, five medical institutions in that country will carry out trials that will end in early March 2022.

The combination of the Oxford / AstraZeneca vaccine with Sputnik V will be studied in five clinical institutions in Russia (REUTERS / Andreas Gebert)

Both the AstraZeneca / Oxford and Sputnik V vaccines involve two doses, a starter and a booster. But Sputnik V uses different viral vectors for its two injections. Both vaccines are based on similar platforms, with a non-replicative viral vector.

So-called viral vector vaccines use harmless modified viruses as vehicles, or vectors, to carry genetic information that helps the body build immunity against future infections.

Trials in volunteers of a COVID-19 vaccine combining the injection of AstraZeneca / Oxford with Sputnik V have already been approved also in Azerbaijan, United Arab Emirates, India, Belarus and Argentina.

In Argentina, different trials were started to study vaccine interchangeability during the last month. One is being carried out in the City of Buenos Aires by the Buenos Aires Ministry of Health. It is done only with people who have received the first dose of Sputnik V more than 30 days ago, are over 21 years old and want to participate voluntarily. The efficacy and safety of different vaccines that already have authorization for emergency use by the Argentine regulatory agency, ANMAT, are tested.

In the City of Buenos Aires, the Ministry of Health launched a study with people who have received the first dose of Sputnik V. The efficacy and safety of different vaccines that already have authorization for emergency use by part of Argentina's regulatory agency, ANMAT (NA)

“The research question for the clinical trial is: Is it as effective and safe to give the first and second doses of the Sputnik V vaccine as the combination with other vaccines from other platforms? ”, Dr. Angela Gentile told Infobae, which is part of the research ethics committee of the trial in the City of Buenos Aires and of the National Commission for Vaccine Safety. The doctor explained it when the registration of volunteers was released.

To make comparisons between the different vaccines, the trial will divide the participants into several arms, including the second dose of Sinopharm and the second dose of AstraZeneca. The final results of the Buenos Aires trial have not yet been released. But the preliminary results would already show that the combination of Sputnik with the other vaccines could be a positive option.

What's more, a vaccine combination trial was also undertaken from the National Ministry of Health, with other provincial jurisdictions. As announced on Monday by the Minister of Health, Carla Vizzotti,part of the doses of messenger RNA vaccines from Moderna that were donated days ago by the United States Government will be included in the trial to evaluate vaccine exchange.

In Argentina, 53% of the population received at least one dose of the COVID-19 vaccine (EFE / Juan Ignacio Roncoroni / File)

This study - explained the Nation's health portfolio - is collaborative and federal: it is coordinated with the participating jurisdictions and researchers from the National Council for Scientific and Technical Research (CONICET). "The objective of the study is to have national evidence for decision-making based on the analysis of immunogenicity and safety of the use of different doses in the same scheme of the vaccines available at the moment in the country," he clarified in a statement.

Combinations between AstraZeneca vaccines, Moderna, Sinopharm and Sputnik-V, and will be compared with the results of people who have received the schemes without doing immunization exchanges.

The provinces of Buenos Aires, Córdoba, La Rioja, Mendoza and San Luis participate in this study. Includes volunteers over 18 years of age vaccinated with a dose of Sputnik V, AstraZeneca or Sinopharm vaccine up to 60 days prior to enrollment, with and without identified risk factors for COVID-19 who remain in the jurisdiction where their study began .

People with immunocompromise due to underlying disease or immunosuppressive treatment are excluded from the study; pregnant and lactating people and those who are registered in the Integrated Argentine Health Information System (SIISA) for having suffered from COVID-19 (symptomatic or asymptomatic); as well as those who have had a severe allergic reaction (anaphylaxis) to any vaccine.

The Minister of Health of the Nation Carla Vizzotti announced that Moderna's vaccines will also be included in a trial to evaluate a combination with Sputnik and the other vaccines that are authorized in the country.

Since the beginning of the year, there have been other trials around the world that have evaluated the vaccine combination, not including Sputnik V. England, Canada, Spain, South Korea and China have already started studies to evaluate other combinations. In South Korea, the health authority reported on May 20 that it would carry out a COVID-19 vaccine combination trial, with doses of the AstraZeneca product with those developed by Pfizer and other companies.

In China, the combination of doses of the COVID-19 vaccine developed by CanSino Biologics ( which will arrive in Argentina according to today's announcement by Vizzotti ) and a unit of Chongqing Zhifei Biological Products is being studied . There, the health authority has recognized that it is studying the possibility of combining the doses of the vaccine developed with different technologies to increase its effectiveness.

https://www.infobae.com/america/ciencia-america/2021/07/27/tras-la-demora-en-la-entrega-seis-paises-estudian-la-combinacion-de-la-vacuna-contra-el-covid-19-sputnik-v-con-otros-inoculantes/