Covid-19 roundup: Pfizer, BioNTech study suggest vaccine works against variants; Researchers say Sinovac's vaccine is 78% effective
Amid heightened concerns about new, largely unknown variants of SARS-CoV-2 that appear to spread more rapidly, Pfizer and BioNTech say they have preliminary evidence that their Covid-19 vaccine is still effective against coronaviruses with one key mutation.
Pfizer partnered with the University of Texas Medical Branch on an in vitro study, in which the academic scientists generated a virus with the N501Y mutation, which they say is shared by the SARS-CoV-2 variants reported in the UK and South Africa. This particular mutation is located in the receptor binding site of the spike protein — the protein that the BNT162b2 vaccine encodes in an mRNA molecule.
They then took sera samples from 20 participants who received the vaccine in the Phase III trial, and tested them against the N501Y mutation as well as a panel of 15 pseudoviruses bearing spikes with other mutations.
The results, they wrote in a preprint, suggested that the antibodies induced by the vaccine “neutralized the virus with the mutation as well as they neutralized virus without the mutation.”
This indicates that the key N501Y mutation, which is found in the emerging U.K and South Africa variants, does not create resistance to the Pfizer-BioNTech vaccine induced immune responses.
While it’s encouraging news, Pfizer and BioNTech noted, more data are needed to monitor the effectiveness of the vaccine in a real-world setting. — Amber Tong
German vaccine candidate fails early-stage trial
The first vaccines for Covid-19 have been developed without much hiccup. But failures — an all-too-common occurrence in biopharma — still crop up.
Today’s reminder comes from Germany, where the German Centre for Infection Research and vaccine maker IDT Biologika said their candidate didn’t prompt the anticipated level of immune reaction in early-stage clinical trials.
The researchers are suspending dosing until they figure out what’s going on. For the trial, which took place in Hamburg, 30 volunteers had received the jab.
IDT was originally hoping to apply for regulatory approval at the end of 2021, Reuters noted. — Amber Tong
Researchers say Sinovac’s vaccine is 78% effective
Brazil’s Butantan Institute has announced that Sinovac’s vaccine candidate is 78% effective — a rate much lower than that of Pfizer/BioNTech and Moderna’s candidates, but high enough to make a difference in developing countries where some worry vaccines won’t be available for years, the Wall Street Journal reported.
The news comes weeks after unnamed sources involved in the Brazilian trials told the WSJ that the vaccine was at least 50% effective. The Chinese candidate, CoronaVac, uses inactivated virus to trigger an immune response. Sinovac and Instituto Butantan, a Brazilian immunobiologic manufacturer, signed a deal back in June to advance clinical trials to Phase III.
While Pfizer/BioNTech and Moderna reported efficacy rates of 95% and 94.5% for their mRNA jabs, respectively, some are concerned it could be years before they reach low-income countries. According to internal papers regarding the WHO, CEPI and Gavi-led COVAX program accessed by Reuters last month, a lack of funds, supply risks and complex contractual arrangements could leave those in poor nations without vaccines until 2024.
Last month, research papers in The BMJ, a peer-reviewed journal by the British Medical Association, said those in low-income countries have little chance of getting inoculated this year. Even if vaccine manufacturers successfully reached their maximum production capacity, at least a fifth of the world’s population might not have access to vaccines until 2022, Anthony So and Joshua Woo predicted in one paper.
“At least 90% of people in 67 low income countries stand little chance of getting vaccinated against covid-19 in 2021 because wealthy nations have reserved more than they need and developers will not share their intellectual property,” Owen Dyer wrote in another paper, citing the People’s Vaccine Alliance.
“There are a large number of developing countries that haven’t been able to secure supplies,” Prashant Yadav, a global health specialist at the Washington-based Center for Global Development, told the WSJ. “This could become a very viable option for them.”
CoronaVac was authorized for emergency use by the Chinese government back in July.
In early December, Sinovac struck a deal with China’s Sino Biopharmaceutical for $515 million to double production capacity. In return, Sino Biopharmaceutical will get a 15.03% interest in Sinovac Life Sciences. At the time, Sinovac said it would be able to pump out up to 600 million doses annually with an added production facility. — Nicole DeFeudis
EU locks down nearly half of Pfizer’s 2021 vaccine supply
In a move that secured nearly half of Pfizer and BioNTech’s 2021 output, the EU has closed a deal with the companies for up to 300 million more doses of their vaccine, Reuters reported Friday.
The bloc had already signed an agreement for 300 million doses in November, potentially giving it access to 600 million total. Pfizer has said it can produce up to 1.3 billion doses this year, and with the EU comprising a population of roughly 450 million people, Friday’s deal could allow for up to two-thirds of the continent to be inoculated should distribution run smoothly.
With the move, EU member states will be able to put in orders for the new doses starting in April, European Commission chief Ursula von der Leyen said at a news conference. Seventy-five million of the additional doses would be delivered in the second quarter of this year, and the rest by the end of 2021.
The agreement includes a possible immediate order for 200 million doses and an additional option to buy another 100 million, the Commission said in a statement.
Friday’s move comes after concern among some member states that Germany’s separate deal with BioNTech last September would create unnecessary competition for the vaccine. The EU was aware of the deal at the time, which Germany first announced Monday and provided for 30 million doses on a bilateral basis.
Also in September, Germany fronted BioNTech about $460 million in funding to help accelerate research and production in the country.
The European Commission authorized the Pfizer/BioNTech vaccine in late December. Pfizer has also signed deals with the US government to provide up to 200 million doses by July 31, 2021, and includes an option to purchase up to 400 million more down the road. — Max Gelman
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