Interim Phase III data suggest Russia’s adenovirus vaccine could be effective enough to rival mRNA jabs from Moderna and Pfizer.
The Sputnik V vaccine had an efficacy rate of 91.6% based on the number of Covid-19 cases tracked 21 days after the first dose was administered, according to
results
published in
The Lancet.
About 20,000 people participated in the Phase III trial.
While AstraZeneca/Oxford and Johnson & Johnson are also taking an adenovirus approach, they’ve reported much lower efficacy rates. AstraZeneca
said
the average efficacy across their full study was 70%, while J&J recently
reported
66% efficacy. Moderna and Pfizer/BioNTech achieved 94.1% and 95% efficacy rates, respectively.
Sputnik V’s protection applied to all age groups, including those older than 60, the Lancet results said. No serious adverse events related to the vaccine were noted, though 45 patients in the vaccine group experienced serious side effects unrelated to the vaccine, according to the Gamaleya National Research Center of Epidemiology and Microbiology.
The researchers believe protective immunity kicks in around 18 days from the first dose.
Sputnik V is believed to remain stable at temperatures around -18 degrees Celsius, which may make it easier to distribute than mRNA vaccines, which need to be kept at extremely cold temperatures. Pfizer and BioNTech’s jab must be shipped in -70 degrees Celsius (-94 degrees Fahrenheit) temperatures — colder than Antarctica — to remain stable.
Russia
registered
the vaccine back in August — and President Vladimir Putin says his daughter took it — well before Phase III studies were completed. The move spurred much backlash, including from the Association of Clinic Trials Organizations, which
wrote a letter
urging Russian Health Minister Mikhail Murashko not to give out an unproven vaccine.
After claiming that Sputnik V was 92% effective back in November, the Russian Direct Investment Fund
tapped
South Korea-based GL Rapha to produce over 150 million doses annually. The National Research Center of Epidemiology and Microbiology in Moscow said that the analysis was based on just 20 Covid-19 cases in its Phase III trial. In comparison, Pfizer analyzed 94 cases.
According to the new interim results, 62 of 4,902 participants in the placebo group had contracted the virus at day 21, versus 16 of 14,964 participants in the vaccine group.
“The development of the Sputnik V vaccine has been criticised for unseemly haste, corner cutting, and an absence of transparency. But the outcome reported here is clear and the scientific principle of vaccination is demonstrated, which means another vaccine can now join the fight to reduce the incidence of COVID-19,” the Lancet study read.
Experts have warned time and time again that early detection of asymptomatic Covid-19 cases is key to curbing the pandemic. On Monday, the US government inked a $231.8 million deal to help an Australian digital diagnostics company manufacture its rapid, at-home coronavirus tests stateside.
Ellume reached an
agreement
with the DOD and HHS to deliver 8.5 million Covid-19 home tests and establish a US-based facility from which it could produce up to 19 million tests per month. The tests got an
EUA
back on Dec. 15, and were previously being made at an Australian site, which is on track to pump out 200,000 tests per day this quarter. Until the US facility is ready for action, Ellume will deliver 100,000 tests per month from Australia.
“We will fulfill the order for these tests at the same time as we ramp up the output across our production facilities, creating more possibilities for retail and private institution use in the future,” CEO Sean Parsons said of the US deal.
Ellume developed its tests with the help of a $30 million grant from the NIH’s RADx initiative, which was created to speed up the production of new testing capabilities. The agency is calling on researchers to develop inexpensive, widely accessible tests to overcome current testing barriers.
Ellume’s nasal test can be done at home, with self-swabbing materials, processing fluid and a Bluetooth analyzer that sends results to your phone within 15 minutes. The results are also sent to local health authorities through a secure cloud connection using your zip code.
The tests cost $30 each, but Parsons
told the
Washington Post
that the price could come down once US manufacturing kicks in — one reason being that the tests would no longer have to be shipped in from Australia.
“We know there are efforts to create even lower cost and more innovative approaches and we welcome those,” Andy Slavitt, President Biden’s senior adviser for Covid-19 response, said at a briefing, per the Post.
Another layer of controversy has surrounded AstraZeneca and Oxford University’s dosing mishap in their late-stage Covid-19 vaccine trial.
According to documents
obtained
by
Reuters,
the partners kept the mistake from around 1,500 of the participants who were given the wrong dose. The pharma sent letters to participants in June presenting the mix-up as an opportunity for Oxford to learn how well the vaccine works at different doses, making no mention that a mistake was made, Reuters reported.
The participants had been given a half dose followed by a whole dose, as opposed to two full doses. AstraZeneca reported better results for this cohort — up to 90% efficacy versus an average efficacy of 70% across the full study. But it was later learned that the half-dose cohort had an
age cap
of 55 years old.
While the vaccine has been authorized in a number of countries including the UK and EU, Germany recommended the vaccine should only be given to those under 65 years old, according to Reuters. And the EU lowered its reported efficacy rate to 60%.
AstraZeneca CEO Pascal Soriot promised back in November to put an end to the questions around its interim Phase III vaccine data by conducting a
new international study.
In mid-December, the company began pursuing a surprising
approach
: combining their vaccine with the Russian-backed Sputnik V vaccine.
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