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www.fdanews.com/articles/200473-astrazeneca-partners-with-russias-gamaleya-research-institute-for-combination-covid-19-vaccine

AstraZeneca Partners With Russia’s Gamaleya Research Institute for Combination COVID-19 Vaccine

December 14, 2020

AstraZeneca (AZ) will soon launch a study evaluating a double-dose regimen of its COVID-19 candidate AZD1222 in combination with adenovirus-based vaccine Sputnik V, developed by Russia’s sovereign wealth fund and using the same technology as the AZ vaccine.

AZ provided scant details on the agreement, saying only it is “considering how it can assess heterologous combinations of different vaccines … and will soon begin exploring with Gamaleya Research Institute in Russia to understand whether two adenovirus-based vaccines can be successfully combined.”

The goal is to administer the virus via different vectors, or delivery mechanisms, which carry genetic instructions prompting the production of antibodies. However, sometimes the immune system can attack a vector and instead neutralize the booster shot or second dose. By switching up vector components, the hope is to reduce this risk and increase vaccine efficacy. The Russian Direct Investment Fund (RDIF) said a new trial assessing the combined vaccines will begin by year’s end.

Russia has received criticism for granting full vaccine approval to Sputnik V prior to the conclusion of phase 3 studies (DID, Aug. 12). The RDIF says widespread inoculations in Russia are under way, with Sputnik V, a double-dose regimen said to be more than 90 percent effective, distributed free to millions of citizens.

AZ’s COVID-19 vaccine development has not been without controversy. The University of Oxford, which co-developed AZD1222, last week released a statement clarifying the dosing error that led to testing a more effective smaller dosage (DID, Dec. 10). This followed the release of a “pooled analysis” showing the vaccine demonstrated an average efficacy of 70.4 percent, calculated by averaging data from two-dose (62 percent efficacy) and one-and-a-half-dose (90 percent efficacy) regimens (DID, Dec. 4).

The Russian government via Twitter made AZ an offer to partner on a combined vaccine in November, on the heels of Russia announcing positive phase 3 interim data for Sputnik V. On Friday, Sanofi and GlaxoSmithKline received a similar offer to collaborate from Russia, after the companies disclosed a significant setback in development of their COVID vaccine (see related story).

In its statement, AZ noted that “the UK government recently announced that it will begin a clinical trial combining adenovirus vaccines with mRNA technology vaccines.” Both Pfizer’s and Moderna’s highly effective vaccines rely on the mRNA technology. It’s not yet known which specific vaccines the UK government plans to combine in its trial. ― Jason Scott