Drugmakers are racing to develop a COVID-19 vaccine, with more than 150 potential vaccines being developed and tested globally.
UK backs human challenge studies of vaccines with $44m fund
Britain said on Tuesday it would back human challenge studies to accelerate the development of COVID-19 vaccines by exposing volunteers to the virus after they had received a vaccine candidate. The government said it would invest 33.6 million pounds ($43.5 million) in the studies in partnership with Imperial College London, laboratory and trial services company hVIVO and the Royal Free London NHS Foundation Trust. If approved by regulators and the ethics committee, the studies would start in January with results expected by May 2021, the government said.
Moderna CEO expects vaccine interim results in November
Moderna Inc Chief Executive Officer Stephane Bancel expects interim results from its COVID-19 vaccine trial in November and that the U.S government could give an emergency use nod in December, the Wall Street Journal reported https://www.wsj.com/articles/moderna-ceo-expects-covid-19-vaccine-interim-results-in-november-11603164001?mod=searchresults&page=1&pos=1 on Monday.
Speaking at the newspaper's annual Tech Live conference, Bancel also said sufficient interim results from the study takes longer to get and that the government's permission to use the vaccine may not come until next year. The first interim analysis of the vaccine's efficacy will happen when 53 people in the entire study get symptomatic COVID-19, the report said.
"That first analysis is likely to occur in November, but it's hard to predict exactly which week because it depends on the cases, the number of people getting sick," the report quoted Bancel as saying. Bancel had told Financial Times last month that Moderna would not be ready to apply for emergency use of its COVID-19 vaccine before Nov. 25 at the earliest.
Bancel also highlighted that a ramping up of production is a challenge. "If one ingredient is missing, we cannot make the vaccine," as per the Journal's report. Moderna is on track to produce 20 million doses of its experimental vaccine by the end of the year, the company had said last month, adding that 25,296 participants had enrolled out of a planned 30,000 in its late-stage study.
First results of Russian coronavirus vaccine trial
Data expected from 5,000-10,000 people
Preliminary results from the late-stage human trial of Russia's main coronavirus vaccine candidate could include data from 5,000-10,000 participants, Denis Logunov, a director at the Gamaleya Institute that developed the vaccine, said on Monday.
Russia's plan to publish preliminary data about the Sputnik V jab as early as November is likely to make it one of the first vaccine developers to share any data from a final stage trial, known as Phase III, but also puts it at odds with competitors. The Sputnik V trial, involving 40,000 volunteers, has been underway in Moscow since the beginning of September. Interim results, when published, will be based on the first 42 days of monitoring participants, Gamaleya developers told Reuters last month.
To meet a November target, the interim results will have to be based on a limited data set - between 5,000 and 10,000 people — due to logistical challenges. Two dozen clinics in Moscow have been racing to administer the vaccine to volunteers, but only around 16,000 people have received the first dose of the two-shot jab so far. There is then a 21-day wait until the second dose can be administered.
Setting a target timeframe for publishing interim results is unusual. Many Western vaccine developers have said the publication of interim results depends on how many volunteers report becoming infected with coronavirus, thereby allowing the placebo and vaccine groups to be compared. A date for when this threshold is met cannot be set in advance.
Russia has been pushing ahead with its potential coronavirus vaccine at full speed, licensing it for domestic use before large-scale trials had even begun. It is also marketing the shot abroad. Interim Phase III results may be useful for foreign regulators deciding whether to procure supplies of Sputnik V or authorise local trials of the jab.
Russia will send Indian regulators weekly data updates from its trial, a source told Reuters on Saturday, after plans to hold Phase III trials in India were briefly put on ice.
Indian regulators knocked back plans to hold large-scale trials of the Sputnik V vaccine saying the scale of initial, Phase I and II trials conducted in Russia earlier this year was too small. An agreement was reached for an adaptive Phase II and III trial to be held in India instead. At least 300 million doses of Sputnik V are expected to be manufactured in India. It will also be produced in Brazil, South Korea and China, Russia's sovereign wealth fund, responsible for marketing the vaccine globally, said on Monday.
India committed to provide COVID-19 vaccine to all citizens
MUMBAI, Oct 20 (Reuters) - Indian Prime Minister Narendra Modi on Tuesday said the government was preparing to supply COVID-19 vaccines to all citizens once they are available. In his address to the nation, Modi urged Indians to continue wearing masks and maintain social distancing rules to prevent further spread of the pandemic ahead of festive season. "I want everyone to remember that we cannot be complacent in our fight against COVID-19," Modi said.
Pfizer, BioNTech start combined trials of vaccine candidate in Japan
Pfizer Inc and BioNTech SE announced on Tuesday the start in Japan of combined Phase I and Phase II clinical trials of their mRNA vaccine candidate against the coronavirus. The study will recruit 160 people aged from 20 to 85, the firms said in a statement. Earlier, they had agreed to supply Japan with 120 million doses of their experimental coronavirus vaccine in the first half of 2021.
Pfizer, which is developing the vaccine with German partner BioNTech, has said it may confirm if the vaccine is effective as soon as this month, but also needs safety data from a global trial of 44,000 people that will not be available until next month. Japan has pledged to secure enough vaccine supply for its entire population by the middle of 2021. In addition to Pfizer, it has struck deals on supplies with AstraZeneca Plc and other overseas makers of vaccine candidates. Clinical trials of AstraZeneca and Oxford University's experimental COVID-19 vaccine resumed in Japan this month after being put on hold over the illness of a British volunteer.
UK lab joins global network to compare coronavirus vaccine candidates
A second British laboratory is joining a global lab network to assess data from potential coronavirus vaccines, set up by a major non-profit health emergencies group to establish the effectiveness of different vaccine candidates. Earlier this month, the Coalition for Epidemic Preparedness Innovations (CEPI) set up the network, allowing scientists and drugmakers to compare vaccines and speed up selection of the most effective shots.
Britain's Medicines and Healthcare products Regulatory Agency said on Tuesday the National Institute for Biological Standards and Control (NIBSC) was joining the scheme, and had received funding from CEPI to develop an international standard for the COVID-19 vaccine. That means the NIBSC will produce a sample of antibody with a defined amount of biological activity that can be used by regulators and vaccine makers to calibrate their tests.
"This is an important initiative providing a service to vaccine developers globally and permits accurate evaluation of candidate vaccines for this pandemic," Dr Mark Page, who is leading the work at NIBSC, said. Public Health England is also involved in the CEPI scheme. Hundreds of potential coronavirus vaccines are in various stages of development around the world, with shots developed in Russia and China already being deployed before full efficacy trials have been done, and front-runners from Pfizer, Moderna and AstraZeneca likely to have final-stage trial results before year-end.