Trial for ‘Covishield’ kicks off in India
Serum Institute of India has started Phase II clinical trials of its Oxford COVID-19 vaccine, the company announced Wednesday.
The vaccine candidate developed by the Jenner Insitute of the Oxford University, now un advanced Phase III trials in the UK, was launched in India under the brand name ‘Covishield’.
The Phase II human clinical trial of Covishield, manufactured by Serum Institute, began at a medical college and hospital on Wednesday.
SII, following government guidelines, chose five volunteers who were given the first dose of vaccine. The volunteers were given the vaccine at Pune’s Bharti Hospital. The volunteers will be monitored by SII, Bharti hospital, and Indian Council of Medical Research (ICMR).
Meanwhile, a top SII executive appealed to the media on Wednesday to avoid speculations about their vaccine until the next announcement had been made.
Several other vaccine candidates, including Bharat Biotech’s Covaxin, are also undergoing trials in the subcontinent.
France expects COVID-19 vaccines from end of 2020 or early 2021
PARIS: New coronavirus vaccines could be available from the end of 2020 or the beginning of 2021, a presentation by French Health Minister Olivier Veran suggested on Thursday.
French Prime Minister Jean Castex said on Thursday the government must move fast to head off a deadly new COVID-19 wave as the virus’s reproduction level has jumped, with infections surging in the Paris region and among young people. – Reuters
China says halt of coronavirus vaccine partnership unrelated to Canada relations
BEIJING: China said on Thursday that the end to a partnership on a coronavirus vaccine between Chinese firm CanSino Biologics and Canada is unrelated to diplomatic relations between the countries.
The Chinese government supports Chinese companies cooperating with other countries according to law, foreign ministry spokesman Zhao Lijian said at a daily news briefing.
Canada’s National Research Council said on Wednesday that it had ended its partnership on a coronavirus vaccine with CanSino, saying the company lacked the authority to ship the vaccine at this time. – Reuters
Moderna vaccine produces antibodies in trial on older people
In a phase 1 trial, Moderna’s coronavirus vaccine produced “consistently high levels” of neutralising antibodies – a key component of the body’s protective response – in older adults, the company said in a statement on Wednesday. Antibody levels in people more than 55 years old were comparable to those seen in younger adults, the company said.
Moderna Inc. presented new safety data from an early trial that provides the first evidence that its COVID-19 vaccine stimulates the immune systems of older people.
The results from Moderna’s early-stage trial, which include data from 20 people in the older age group, were presented Wednesday to the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices. The findings are important because older adults often don’t respond as well to vaccines as younger adults.
The trial used the same dose of the vaccine that’s now being given to subjects in a final-stage trial. The dose elicited antibody levels higher than those typically seen in people recovering from the virus, Moderna said.
The shares rose as much as 8.1% in New York.
The case for Moderna’s vaccine becoming one of the best shots to fight the coronavirus “got stronger today,” Moderna chief executive officer Stephane Bancel said in an interview. The findings in older people are “a big deal,” he said.
Moderna’s vaccine uses genetic material called messenger RNA to instruct the body’s own tissue to make viral proteins that induce the immune response. Bancel attributed the consistent effects of the vaccine, in part, to biodegradable coatings Moderna has developed that allow higher doses of messenger RNA while limiting side effects.
While the vaccine is associated with a variety of issues including chills, fatigue, fever, headache and muscle pain, there were no serious adverse events in the 100-microgram dose that’s being used in the final-stage trial, according to a copy of Moderna’s slide presentation from the meeting.
Moderna is “totally on track” for enrolling all 30,000 patients into its phase 3 trial by September, Bancel said. “Now we are really going at full speed.”
The company said on August 21 that it had already enrolled more than 13,000 patients in the trial. Results are possible by late fall.
An emergency use authorisation, which allows medical products to be deployed without final safety and efficacy data, might make sense for a coronavirus vaccine, but only for limited groups of high-risk people, Bancel said. Those might include health-care workers or elderly people with pre-existing conditions, Bancel said, noting that federal regulators will ultimately decide what to do.
Broad emergency authorization of an experimental vaccine for healthy Americans wouldn’t be appropriate, Bancel said. Regulators need time to review all the data to make sure the vaccine gives sufficient benefit without unexpected risks, he said. He expects a review for full approval of a coronavirus vaccine to take months once the data is in.
Bancel said that Moderna plans to publish all its vaccine trial data in a major journal so that doctors can decide about the safety and efficacy of the vaccine for themselves. The company wants to produce the highest quality data so the public has confidence in its mRNA technology, he said.
“We don’t want to cut corners,” he said.
The company earlier published data from the same early-stage trial showing that the vaccine produced neutralizing antibodies against the coronavirus in younger adults. Triggering neutralizing antibodies in older patients is important as they are some of the most severely affected by COVID-19. – Bloomberg
South Africa ‘may be first in region’ to produce COVID-19 vaccine
South Africa may sign a deal to help produce a COVID-19 vaccine, potentially boosting access to immunization on a continent with limited manufacturing capacity.
The Coalition for Epidemic Preparedness Innovations (CEPI), a global organisation funding vaccine development, is considering the Cape Town-based Biovac Institute as a fill-finish site, according to Helen Rees, the chair of the organization’s Scientific Advisory Board.
The state vaccine company is one of few in the country that has the capacity to package doses into sterile dispensers if clinical trials are successful.
“What we are looking at is partnerships,” Morena Makhoana, Biovac’s chief executive officer, said in response to questions. “Once that is signed, we will be able to make an announcement.”
A manufacturing agreement will “put Africa on a similar path to other continents, much like the clinical trials are doing,” he said.
Clinical studies in South Africa
South Africa is the only country in Africa that hosts several clinical studies.
- AstraZeneca Plc and University of Oxford vaccine trial: 2,000 people in South Africa
- Novavax Inc. is starting a Phase 2b clinical trials in South Africa.
- Johnson & Johnson: One-fifth of the 60,000 volunteers (12,000) expected to enroll worldwide in J&J’s COVID-19 vaccine trial will be in South Africa.
Glenda Gray, the chief executive officer of the South African Medical Research Council, announced the Johnson & Johnson trial in the country.
“COVID-19 has really thrown into focus that we have very limited capacity for vaccine manufacturing across the African continent, even in countries like South Africa,” said Rees. “But there’s tremendous interest and we need to have more countries being able to manufacture vaccines.” – Bloomberg
Peru seeks 6,000 volunteers for China vaccine trial
LIMA: Peru on Wednesday began registering volunteers for clinical trials of a Chinese vaccine against the coronavirus.
Six thousand volunteers, who must be aged between 18 and 75 and not have contracted the virus, will be recruited by Cayetano Heredia and San Marcos universities via a dedicated website.
“The universities will select 3,000 volunteers each,” San Marcos rector Orestes Cachay told reporters.
The vaccine, being developed by Chinese company Sinopharm, will be administered by injection.
According to Peruvian researchers in charge of the clinical trials, two strains of the virus – the Wuhan strain and Beijing strain – and a placebo will be randomly given to volunteers. “A technical team from China will arrive in the coming days, totaling 38 people, to implement the operational part of the project,” Cachay told TV channel N.
Peru trial expected to last until December
President Martin Vizcarra announced last week the country would participate in clinical trials of vaccines being developed in China, Britain, the United States and Germany.
Peru, with a population of 33 million, has the third-highest number of deaths from the pandemic in Latin America, after Brazil and Mexico. Per capita, it has the region’s highest death rate, with 843.5 deaths per million inhabitants.
More than 28,000 people have died of COVID-19 in the country, which has registered more than 600,000 infections so far. – AFP
‘Operation Warp Speed’ pushes vaccine platforms
WASHINGTON: The White House has secured eight experimental coronavirus vaccines through its “Operation Warp Speed” effort, seeking to hedge its bets on different technologies, according to a top adviser to the program.
Moncef Slaoui, the operation’s chief adviser, and Matthew Hepburn, a Department of Defense official, outlined the federal criteria for selecting and securing vaccine candidates in an essay in the New England Journal of Medicine (NEJM) on Wednesday.
4 types of vaccines
Slaoui and Hepburn wrote that that each candidate selected for the ‘Warp Speed’ portfolio must employ 1 of 4 types of vaccine platform technologies believed by the US to likely yield a safe and effective shot. That includes newer technologies like so-called messenger RNA, as well as older ones using a weakened form of a pathogen to induce an immune response without causing disease.
So far, the US government has announced deals for supplying six COVID-19 vaccines candidates. Those shots are being developed by:
- Johnson & Johnson,
- Moderna Inc.,
- Pfizer Inc. in partnership with BioNTech SE,
- The University of Oxford in collaboration with AstraZeneca Plc,
- Sanofi with GlaxoSmithKline Plc, and
- Novavax Inc.
The final two unnamed candidates will enter trials soon, Slaoui and Hepburn said.
Requirements for Operation Warp Speed
Operations Warp Speed’s other requirements for inclusion in its portfolio are robust pre-clinical or early stage vaccine data, the ability to enter large, late-stage trials in the summer or fall, and the ability to manufacture at scale, with more than 100 million doses ready by mid-2021.
Bloomberg reported in June that Merck & Co. had also been tapped for the operation’s portfolio, though no formal announcement has been made. One of Merck’s two vaccine candidates – based on a measles shot used in Europe – enters the clinic this month. A spokeswoman for Merck declined to comment on whether the company had reached an agreement with the U.S.
‘Tens of millions of doses’
Operation Warp Speed is an effort that brings together the Department of Health and Human Services (DHHS), the Biomedical Advance Research and Development Authority (BARDA) and the Department of Defense (DoD), as well as other agencies, to expedite the development, manufacturing and distribution of coronavirus inoculations and treatments.
On Wednesday, Slaoui and Hepburn reiterated that the government wants to have tens of millions of doses of a COVID-19 vaccine approved or authorised for use by the end of 2020, and as many as 300 million doses available and deployed by mid-2021.
Slaoui and Hepburn said the US will ensure that all selected vaccines enroll 30,000 to 50,000 participants in late-stage trials, and that trial endpoints are “harmonized to permit appropriate comparisons.”
The US is working to ensure that “the most vulnerable and at-risk persons will receive vaccine doses once they are ready,” Slaoui and Hepburn said in the New England Journal of Medicine report. But that will also depend on the relative performance of each vaccine in various populations – Bloomberg
Moscow announces advanced trials for new COVID-19 vaccine
MOSCOW: The mayor of Moscow invited residents Wednesday to join trials of a coronavirus vaccine that Russia approved for use earlier this month, in what officials described as a breakthrough on par with the Soviet Union’s launch of the world’s first satellite in 1957.
The world’s first vaccine against the coronavirus to receive a government go-ahead has caused unease among international medical experts, who called Russia’s fast-tracked approval and failure to share any data supporting claims of the vaccine’s efficacy a major breach of scientific protocol.
Scientists around the world say any widely-used vaccine should first be tested in advanced trials involving tens of thousands of people to prove it is safe and effective before being licensed.
In his invitation to the Russian capital’s residents, Moscow Mayor Sergei Sobyanin appeared to announce those kind of broad studies would be launched soon. He said the “post-registration research” will last six months and involve 40,000 people.
Sobyanin encouraged Moscow residents to sign up, arguing that the vaccine was based on longtime previous research and proven to be safe.
‘Help defeat the coronavirus’
“We all were eager to see the creation of a vaccine, and now we have it,” Sobyanin said. “Now, Moscow residents have a unique chance to become the main participants in clinical research that will help defeat the coronavirus.”
The Russian Direct Investment Fund that bankrolled the vaccine said it will facilitate similar trials in five other countries, which it didn’t name.
“The post-registration clinical trial will allow for a permanent registration certificate and expansion of the circle of possible vaccine recipients, including the 60″ age group,” the fund said in a statement.
Scientists at the World Health Organization said last week that although they had begun discussions with Russia about its vaccine, they had not yet received any detailed data about it.
In announcing the vaccine’s approval on Aug. 11, Russian President Vladimir Putin said one of his two adult daughters already had been inoculated with it. He said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, although Russian authorities have offered no proof to back up claims of safety or effectiveness. – AP
White House chief of staff hopes for virus vaccine by the fall
WASHINGTON: White House Chief of Staff Mark Meadows says he’s looking forward to the US having a vaccine for COVID-19 by the fall, a faster timeline than top government scientists have sketched out.
Meadows told Politico he’s “optimistic that one of the seven or eight candidates that we have will actually get approved. And hopefully be able to be deployed by this fall.”
Meadows didn’t directly say whether the Food and Drug Administration would authorise emergency use of a vaccine, which it did recently for donated blood plasma from people who recovered from COVID-19. Meadows says, “We’re going to make sure it’s good science and the efficacy and the safety of those vaccines are well tried.” – AP
Sweden: 10 million doses of AstraZeneca vaccine
STOCKHOLM: Sweden said Thursday (August 20, 2020) it had agreed to take part in the European Union’s deal with pharmaceutical group AstraZeneca to secure a supply of a coronavirus vaccine as soon as it is approved.
The deal means Sweden, a country of 10.3 million people, would get around 2 million doses of the vaccine in an initial phase, and 2 million more in a later phase.
“Within two weeks we will have three more (vaccine) agreements to consider, and after that there will be another three or four in a month or two. We are negotiating with everyone to make sure we are covered,” Sweden’s national vaccine coordinator Richard Bergstrom told reporters.
AstraZeneca said in July that its vaccine, developed together with the University of Oxford, should be available by the end of the year. Sweden, which has made headlines for its softer approach to the new coronavirus, said on Thursday it had 85,810 confirmed cases and 5,805 deaths. – AFP
EU reaches virus vaccine deal with CureVac
BRUSSELS: The EU said Thursday (August 20, 2020) it has concluded talks with German pharmaceutical firm CureVac, aiming to secure 225 million doses of a potential coronavirus vaccine.
It is the fourth agreement the bloc has reached with companies working on a potential vaccine against the virus, after deals with Sanofi-GSK, Johnson and Johnson and AstraZeneca.
“The envisaged contract with CureVac would provide for the possibility for all EU member states to purchase the vaccine,” the European Commission, the bloc’s executive arm, said in a statement. An agreement to buy the vaccine will come once it has been shown to be safe and effective, the commission said.