Novavax Inc has started the first phase 3 clinical trial of its covid-19 vaccine in the UK, and plans to enrole and immunise up to 10,000 individuals between 18-84 years of age over the next four to six weeks, the company said in a statement today.
The development assumes significance as Serum Institute of India is in a partnership with Novavax to produce about 1 billion doses of its vaccine, which includes production of the antigen and use of the adjuvant—a component used to boost immune response—supplied by the US-based firm.
The agreement forms the backbone of Novavax’s plans to scale-up its manufacturing capacity, currently at up to 2 billion annualised doses, once all capacity has been brought online by mid-2021.
Serum Institute will start the third phase of trials in India in the second half of October after the vaccine is manufactured, and the trial will be led by Indian Council of Medical Research’s National AIDS Research Institute (NARI) in Pune, minister of state for health and family welfare Ashwini Kumar Choubey told Lok Sabha last week.
The Pune-based firm has declined to comment on the Novavax trials as well as its own in India.
As part of Novavax’s trials in the UK, half the 10,000 participants will receive two intramuscular injections of the vaccine, administered 21 days apart, while half of the trial participants will receive placebo.
The trial has been designed to enrol at least 25% of participants above 65 years of age and to prioritise groups that are most affected by the respiratory disease. The trial will also provide a licensed seasonal influensa vaccine to up to 400 participants as part of a co-administration sub-study.
The Novavax vaccine is a protein subunit vaccine, which includes the company’s proprietary adjuvant. The vaccine can be stored in an unfrozen, liquid formulation at 2-8°C, allowing for distribution using standard vaccine channels.
Serum Institute is also in a pact with AstraZeneca plc for production of the chimpanzee adenovirus-based vaccine candidate that is developed by the UK-based company and University of Oxford. The Oxford vaccine is currently undergoing phase 3 clinical trials across 17 sites in India.
… Russian govt in receipt of first trial batch of Sputnik-V
Meanwhile, Russian govt have received the first trial batches of “Sputnik V” coronavirus vaccine, according to the Russian Health Ministry. The Covid-19 vaccine was reportedly developed for civilian circulation by the N. F. Gamaleya Federal Research Center for Epidemiology and Microbiology.
The ministry issued a statement saying: “All regions have received the first trial batches of the Gam-COVID-Vac vaccine (Sputnik V) for the prevention of the novel coronavirus infection developed by the N. F. Gamaleya Federal Research Center for Epidemiology and Microbiology.”
The Covid vaccine is being used in various Russian regions, with medical workers considered the priority. As per the federal information monitoring system, there are more than 27,000 marked packages of the vaccine so far.
Moscow Mayor Sergei Sobyanin on Friday ordered the elderly to stay at home and recommended employers allow home working after the Russian capital saw a sharp rise in virus cases.
Sobyanin’s message came after virus figures that had remained steady for several months climbed steeply in recent days in Russia, the world’s fourth most affected country, and particularly in Moscow, where current case numbers are the highest since late June.
Sobyanin said Muscovites over 65 years old should stay at home from Monday and shop rarely, while walks outside remain unrestricted.
At the beginning of the virus lockdown, Sobyanin brought in harsh measures including cancelling seniors’ free travel passes.
“Unfortunately we see a significant increase in the number of confirmed cases in Moscow in recent days,” Sobyanin said in his official blog.
New coronavirus cases in Moscow on Thursday reached their highest level since June 23, at 1,050, and Sobyanin said there had a been a “serious” increase in hospital admissions.
On Friday, he warned that simultaneously catching the common cold and the virus as winter approaches was particularly dangerous for elderly people and those with chronic illnesses.
“So from September 28, we are asking you to stay at home,” he said.
The mayor’s decree presents this as a compulsory rule, with exceptions for medical care, shopping, walking dogs and commuting to work.
Sobyanin said those in the risk groups should work from home or take vacation if possible.
He also told company heads: “I firmly ask and recommend you to move as many of your staff as possible to home-working.”
Employers should offer virus testing and temperature checks, he said.
Warning the virus is “not conquered yet,” he called for Moscow residents to wear face masks and gloves on public transport and in shops, a rule already in place but widely flouted.
At the peak of lockdown Sobyanin only allowed people to go to their nearest shop or walk a dog, while those using public transport or cars needed electronic passes.
“We all really don’t want to go back to he harsh restrictions of spring,” Sobyanin said. “I hope we can avoid this.”
Russia has confirmed 1,128,836 coronavirus cases and almost 20,000 deaths.
It has boasted of creating the world’s first approved coronavirus vaccine, Sputnik V, although it is still undergoing clinical trials.