Covid-19 roundup: Pfizer/BioNTech/Moderna test vaccines against new UK variant; Ocugen strikes deal for US rights to PhIII vaccine
Both Pfizer/BioNTech and Moderna have said their candidates should protect against a new variant of coronavirus that has been detected in the UK, and are conducting tests to prove it.
BioNTech CEO Ugur Sahin has said it’s “highly likely” that their vaccine developed with Pfizer will be effective against the new variant, which scientists worry could spread more easily than the current strain. There’s no evidence right now that the mutation causes more serious illness. But to be safe, multiple countries are blocking travel from the UK.
“We don’t know at the moment if our vaccine is also able to provide protection against this new variant,” Sahin said in a news conference, per ABC News. “But scientifically, it is highly likely that the immune response by this vaccine also can deal with the new virus variants.”
While further study will be necessary to confirm the theory, Sahin noted that the proteins on the variant are 99% similar to prior strains. If needed, the vaccine could be adjusted in 6 weeks, he said, according to ABC.
Moderna has also said its vaccine likely protects against the new variant, according to Forbes. In a statement, they said data suggest their candidate’s “vaccine-induced immunity would be protective against the variants recently described in the U.K.”
The first doses of Pfizer/BioNTech’s recently approved vaccine were given out across the US last week, and Moderna’s vaccine was not far behind. On Monday, President-elect Joe Biden received a shot as part of a campaign to convince other Americans to get vaccinated.
Ocugen strikes deal for US rights to PhIII vaccine
Pennsylvania-based Ocugen and has inked a deal with India’s Bharat Biotech to co-develop its whole-virion inactivated vaccine candidate Covaxin for the US market.
The candidate, which was developed through a collaboration with the Indian Council of Medical Research/National Institute of Virology, is currently in a Phase III trial in India with 26,000 volunteers. It has already been tested in 1,000 people in Phase I and II trials there, which turned up “promising safety and immunogenicity data,” according to the companies.
As part of the deal, Ocugen will have US rights to the candidate, where it will be responsible for clinical development, registration and commercialization in collaboration with Bharat. The companies kept quiet about the financial terms of the deal, but said they expect to have the final details ironed out in the next few weeks.
“COVAXIN utilizes a historically proven approach to vaccine design,” Harvey Rubin, a member of Ocugen’s Vaccine Scientific Advisory Board, said in a statement. “The adjuvanted inactivated virus vaccine candidate elicited strong IgG responses against spike (S1) protein, receptor-binding domain (RBD) and the nucleocapsid (N) protein of SARS-CoV-2 along with strong cellular responses in Phase 1 and 2 clinical trials. COVAXIN offers a vaccine candidate that is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus.”
Back in August, Bharat chairman Krishna Ella said the company is prioritizing safety and quality over speed, per a Business Standard report.
European Commission authorizes Pfizer/BioNTech vaccine
Weeks after it was greenlighted in the UK, Pfizer and BioNTech’s Covid-19 vaccine was given the thumbs-up by the European Commission.
The official word came hours after the EMA’s Committee for Medicinal Products for Human Use recommended the agency move forward with conditional marketing authorization on Monday. The first shots could be delivered in some states as early as Sunday, according to the BBC.
The vaccine will be marketed in Europe as Comirnaty, a combination of the terms Covid-19, mRNA, community and immunity, according to a statement by Pfizer and BioNTech.
“As a company founded and headquartered in the heart of Europe, we are looking forward to delivering the vaccine to Europeans in the upcoming days,” BioNTech CEO Ugur Sahin said in a statement. “We believe that vaccinations may help reduce the number of people in high-risk populations being hospitalized. Moving forward, we will continue to collect efficacy and safety data in participants for an additional two years and test the vaccine against additional mutations that might occur.”
In November, Pfizer and BioNTech inked a deal with the EC for 200 million doses in 2020 in 2021, with the option to secure up to 100 million more. The doses will be delivered in stages, and will be produced at BioNTech’s German manufacturing sites and Pfizer’s site in Belgium. The companies say they can deliver 50 million shots globally by the end of this month and up to 1.3 billion by the end of next year.
BioNTech plans on increasing its manufacturing supply next year with a third site in Marburg, Germany. Pfizer’s Puurs, Belgium site will be used primarily for European supply, as well as a back-up supply to Kalamazoo, MI.
More than 40 countries have authorized the vaccine so far, including the 27 EU member states, the UK, Canada, the US, Mexico, Saudi Arabia, Singapore, Bahrain, Chile and Jordan.
“With the pandemic still raging in many countries, we are continuing to work around the clock to bring this vaccine to the world as quickly, efficiently and equitably as possible,” Pfizer CEO Albert Bourla said in a statement.
Brazil trials show Sinovac candidate is at least 50% effective — report
After holding onto efficacy data for Sinovac’s Covid-19 vaccine a bit longer than expected to get a more complete analysis, those involved in Brazilian clinical trials say the candidate is more than 50% effective.
Unnamed sources told the Wall Street Journal that the Chinese vaccine passed the 50% efficacy threshold that international scientists have set as a standard, but didn’t give any more specifics.
“Everyone is hoping for an efficacy rate above 90%,” Domingos Alves, a professor at Ribeirão Preto Medical School in São Paulo told the WSJ. “The results from the first phases of trials were very good.”
Sinovac‘s candidate, CoronaVac, implements inactivated virus to trigger an immune response.
Last week, São Paulo Gov. João Doria announced an efficacy readout would be delayed by one week — until Dec. 23 — to get a larger sample size, according to a Reuters report. Trial organizers said back in November that a first Phase III look at the Chinese candidate would come early this month. And Doria has promised to begin vaccinations on Jan. 25, per Reuters.
Back in November, the Brazilian trial was briefly halted following the death of a participant. Brazil reversed its halt soon after, and the state government revealed that the volunteer had died by suicide.
The US’ two leading vaccines, developed by Pfizer/BioNTech and Moderna, tout efficacy rates of 95% and 94.1%, respectively. Scientists involved in the CoronaVac trials say they expect to track an efficacy rate similar to those vaccines, according to the WSJ.
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