Covid-19 roundup: EMA starts rolling review of Russia's Sputnik V; Novavax says shot is 51% effective against variant in South Africa
The EMA has started a rolling review of Sputnik V, the Russian vaccine that holds the dubious title of the world’s first registered jab for Covid-19.
Seven months after the controversial clearance in Russia, Europe’s human medicines committee says it’s convinced to start looking at the application by data indicating that the adenovirus-based vaccine triggers the production of antibodies and immune cells against the SARS-CoV-2 coronavirus.
As with previous rolling reviews of the Pfizer/BioNTech and AstraZeneca/Oxford vaccines, a marketing authorization application has not yet been formally submitted. R-Pharm Germany — the Gamaleya National Centre of Epidemiology and Microbiology’s partner in Europe — is tasked with the filing.
While Sputnik V utilizes the same technology platform as AstraZeneca and J&J, the two-dose regimen uses two different viruses for the prime and booster shots: Ad26 for the first and Ad5 for the second. Scientists reported efficacy of 92% in a Phase III trial, surpassing other adenovirus-based vaccines and rivaling its mRNA counterparts, although the evidence offered was notably slimmer.
As EU leaders in Brussels struggle with delays in vaccine supply and rollout, two member states have individually turned to Russia for their own vaccination campaigns.
Hungary was the first to bypass the EMA, authorizing and purchasing not the Russian vaccine but also an inactivated virus vaccine from China’s Sinopharm.
Earlier this week, Slovakia announced that it’s purchased 2 million doses of Sputnik V, although its drug regulator has yet to give a green light. — Amber Tong
Novavax says shot is 51% effective against variant in South Africa
Novavax’s vaccine candidate was 51% effective against the B.1.351 variant in HIV-negative patients, according to results from a study conducted in South Africa.
A total of 4,387 volunteers were enrolled in the Phase IIa/b study trial, including HIV-positive patients. The vaccine group included 2,199 participants who got two doses of Novavax’s jab 21 days apart, according to a preprint in medRxiv. Nearly 93% of cases in the study were discovered to be caused by the B.1.351 variant.
Overall efficacy in HIV-negative patients who were seronegative at baseline was 60.1%, researchers reported. Efficacy including HIV-positive patients was 49.4%.
About 30% of the participants were seropositive at baseline, indicating prior Covid-19 infection. However, researchers found no significant difference in protection for that group compared to those who were seronegative at baseline.
“The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, which was predominantly mild to moderate and due to the B.1.351 variant, while evidence of prior infection with the presumptive original SARS CoV-2 did not confer protection against probable B.1.351 disease,” the preprint states.
The news comes just over a month after Novavax announced its vaccine was 89.3% effective at stopping symptomatic Covid-19 in its Phase III study in the UK, as of the first interim analysis. The readout was based on 62 confirmed cases of symptomatic Covid-19, 56 of which came in the placebo group.
Already running behind others in the vaccine race, Novavax delayed the start of its US/Mexico Phase III trial a second time back in November. Manufacturing issues, which were to blame for the first delay, appeared to be at play in the second holdup as well. — Nicole DeFeudis
UK to fast-track vaccines for Covid-19 variants — report
The UK’s regulatory agency says it will fast-track vaccines for Covid-19 variants, using an accelerated process similar to the one used for seasonal flu vaccines, according to a Reuters report.
The Medicines & Healthcare products Regulatory Agency (MHRA) said researchers will be allowed to measure protection by antibodies produced in the blood, rather than conducting lengthy clinical trials, Reuters reported on Thursday morning. They’ll still need safety data, and data from original clinical trials and real-world inoculations are fair game.
“Our priority is to get effective vaccines to the public in as short a time as possible, without compromising on safety,” said Christian Schneider, the MHRA’s CSO, per the news agency.
AstraZeneca, Pfizer and Moderna, which have shots OK’d for use in the UK, are all working to address new variants. Last week, Moderna’s Stéphane Bancel told Endpoints News that vials containing variants of their vaccine to beat new variants of the virus had arrived at the NIH headquarters in Bethesda, where they will begin rapid clinical testing. — Nicole DeFeudis
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