The US government has ordered 300 million doses of a potential COVID-19 vaccine being developed by AstraZeneca and Oxford University and hopes first doses can be made available by October, the Department of Health and Human Services said Thursday.
"This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021," HHS Secretary Alex Azar said in a statement.
The US has the world's worst coronavirus affliction, with over 1.52 million cases, including 91,664 deaths, according to data from its Centers for Disease Control and Prevention as of May 20.
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US immunotherapy company Inovio Pharmaceuticals Inc on Wednesday said its experimental vaccine to prevent coronavirus infection was shown to produce protective antibodies and immune system responses in mice and guinea pigs.
"We saw antibody responses that do many of the things we would want to see in an eventual vaccine," said Dr. David Weiner, director of the vaccine and immunotherapy center at the Wistar Institute, which has collaborated with Inovio.
"We are able to target things that would prevent the virus from having a safe harbor in the body."
Inovio, which began human testing of its vaccine in April, said preliminary results from that trial are expected in June.
The 40 healthy participants in the Phase 1 trial are given 2 shots, 4 weeks apart, of the vaccine, called INO-4800, and then followed for 2 weeks.
"We are already seeing safety data and it has been benign," Dr. Katherine Broderick, head of research and development at Inovio, told Reuters. "Some people have slight redness of the arm."
Once the preliminary data are in, she said Inovio expects to approach the US Food and Drug Administration for authorization to move into a Phase 2/3 trial, which could happen in July or August.
Inovio said the latest animal study results, published in the journal Nature Communications, validate its DNA medicines platform and build on previous positive clinical trial data for its experimental vaccine against a different, but related, coronavirus that causes Middle East Respiratory Syndrome.
That vaccine and INO-4800 are made using newer technology that focuses on specific genes on the outer "spike" portion of the virus.
Inovio said the newly published data demonstrate virus neutralizing activity using 3 separate testing procedures. Study authors also said they detected the antibodies in the lungs of the vaccinated animals.
Inovio next plans to test the vaccine in larger animals including rabbits and monkeys, and to undertake "challenge" studies in mice, ferrets and monkeys, Broderick said.
Challenge studies involve intentionally giving the virus to an animal and then seeing if the vaccine prevents infection.
There are currently no approved treatments or vaccines for COVID-19, the disease caused by the new coronavirus. Experts predict a safe and effective vaccine could take 12 to 18 months to develop.
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THE HAGUE - A vaccine for the novel coronavirus could be ready in a year's time under an "optimistic" scenario, based on trials that are underway, the European Medicines Agency (EMA) said Thursday.
The Amsterdam-based EU agency also played down fears expressed by the WHO that the virus might never go away, saying it would be "surprised" if a vaccine was not found eventually.
"We can see the possibility if everything goes as planned that some of them (vaccines) could be ready for approval in a year from now," Marco Cavaleri, the EMA's head of vaccines strategy, told a video news conference.
"These are just forecasts based on what we are seeing. But again I have to stress that this is a best-case scenario, we know not all vaccines that come into development may make it to authorization, and may disappear," he added.
"We know also that there may be delays."
The EMA approves medicines for the 27-nation European Union.
Because of the coronavirus pandemic, the EMA said it had sped up the process for authorizing vaccines, which it said can often take 10 to 15 years to approve.
Cavaleri, however, said he was "a bit skeptical" about reports that a vaccine could be ready as soon as September.
"We would be happy to be proved wrong, but we are basing that on our experience" of how long it takes to test and approve vaccines, he said.
'SUFFICIENTLY OPTIMISTIC'
Work on treatments for patients who have already caught coronavirus were "more advanced and are already being tested," Cavaleri added.
The EMA has not yet authorized remdesivir, an anti-viral shown in US trials to reduce recovery times in patients, but said earlier this week that "compassionate" use for patients with severe COVID-19 should be expanded.
The agency, meanwhile, played down fears expressed by the World Health Organization that the virus "may never go away."
"I think it's a bit early to say but we have good reason to be sufficiently optimistic that some vaccines will make it," said Cavaleri.
"I would be surprised that if at the end of the day we don't have any vaccine for COVID-19."
With the world engaged in a race to find a cure, the agency said it would "ensure" any vaccine is available for European citizens, no matter where it is developed.
France on Thursday cried foul after pharmaceutical giant Sanofi said it would reserve first shipments of any vaccine for the United States, since the US government was helping fund the French multinational's vaccine research.
"Since it's a worldwide problem I hope we can have early access," said Noel Wathion, deputy executive director of the EMA.
Agence France-Presse
Moderna Inc and Swiss contract drugmaker Lonza Group AG said Friday they would accelerate the manufacturing of the US drug developer's potential coronavirus vaccine.
The announcement comes at a time when drugmakers are pausing clinical trials for other disease areas as they focus on testing potential treatments for the coronavirus.
The experimental vaccine, mRNA-1273, is being tested in early-stage trial by the US National Institutes of Health, with Moderna expecting to begin mid-stage trial in the second quarter.
Under the 10-year collaboration agreement, the companies aim to manufacture up to a billion doses per year as technology transfer is expected to begin in June, and the first batches of the vaccine are expected to be manufactured in Lonza US in July.
"Over time, the parties intend to establish additional production suites across Lonza's worldwide facilities, ultimately allowing for the manufacture of material equivalent to up to 1 billion doses of mRNA-1273 per year for use worldwide," the statement added.
The disease, which infected more than 3.2 million people worldwide and killed around 232,000, set off a race among drugmakers to find an antidote.
Earlier this month, Moderna got a $483 million funding from a US government agency to accelerate its COVID-19 vaccine development.
Separately, Basel-based Lonza's pharmaceuticals, biotech and nutrition business has received more than 40 inquiries regarding projects relating to COVID-19, the company said earlier in April.
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