The United States on Tuesday announced it was providing $1.6 billion in funding for the development and manufacture of a COVID-19 vaccine candidate produced by biotech firm Novavax, the largest amount awarded under Operation Warp Speed.
Separately, the US also said it was providing $450 million to Regeneron for its experimental COVID-19 treatment and prophylaxis, a combination of two antibodies.
Under the terms of its agreement with the Department of Health and Human Services (HHS) and Department of Defense, Novavax agrees to deliver 100 million doses of its vaccine, potentially by the end of the year.
"We are honored to partner with Operation Warp Speed to move our vaccine candidate forward with extraordinary urgency in the quest to provide vital protection to our nation's population," said Stanley Erck, the company's president and CEO.
The final stage Phase 3 trial of its vaccine, called NVX-CoV2373, is set to take place this fall.
The Maryland-based company uses insect cells to grow synthesized pieces of the SARS-CoV-2's "spike protein," which the virus uses to invade cells, in order to trigger the human body's immune response.
It also uses an "adjuvant," a compound that boosts the production of neutralizing antibodies.
In the spring, the company said it had proven the efficacy of a seasonal flu vaccine it had developed using similar technology.
The amount awarded to Novavax by the US is higher than the $1.2 billion given to the Oxford University vaccine that is being developed by AstraZeneca.
Under Operation Warp Speed, the US is aiming to deliver millions of doses of safe and effective vaccines for COVID-19 in 2021.
Also Tuesday, the US said it was providing New York-state based Regeneron with $450 million to scale up manufacture of its COVID0-19 antibody treatment.
The company, which announced on Monday it was entering late stage human trials, estimates that it could have between 70,000 and 300,000 treatment doses, with the first available by late summer.
The drug, called REGN-COV2, is a combination of two antibodies that block the coronavirus' spike protein.
Regeneron scientists evaluated thousands of antibodies harvested from genetically-modified mice with human immune systems and from humans, identifying the two they found to be most potent, while not competing against each other.
The company uses a multi-antibody strategy to decrease the chances that the virus will mutate in order to evade the blocking action of a single antibody, an approach it detailed in a recent study in Science.
Last year, a triple antibody cocktail developed by Regeneron was shown to be effective against the Ebola virus.
Agence France-Presse
JOHANNESBURG - South African drug company Aspen could provide 10 million dexamethasone tablets within a month, Chief Executive Stephen Saad told Reuters on Tuesday.
Results from a trial showed that dexamethasone reduced death rates by about a third compared with a placebo in severely ill hospitalized COVID-19 patients, University of Oxford scientists said last week, calling the discovery a major breakthrough.
"Aspen has looked at the short-term needs and can provide 10 million tablets in the next 3 to 4 weeks. We would look to ramp up further should there be a need for additional product," Saad said without indicating current production volumes.
South Africa's biggest supplier of drugs, with a 22 percent market share in sub-Saharan Africa, manufactures both the injectable and tablet forms of dexamethasone, which is mainly used for treatment of tumors, asthma and other respiratory ailments.
The South African government has contacted Aspen to source the drug not only for its domestic market but also for rest of the continent, the company said on Monday.
The company has asked the government to indicate required volumes across the continent, Saad said. "Once they give us a sense, we can work out the supply," he added.
South Africa's health ministry on Friday said that the government had a stock of 300,000 ampules of dexamethasone and could secure supplies from local suppliers.
Saad said the recent revelation by scientists at the University of Oxford had brought in sudden demand for the drug and the company had received orders from the World Health Organization, UNICEF and other bodies.
"We are trying to make sure there is no panic-buying," he said.
-reuters-
PARIS - French pharmaceutical giant Sanofi said Tuesday it would invest $425 million to expand its vaccine development venture with US start-up Translate Bio as they aim to find a COVID-19 vaccine by next year.
The companies have been working together since 2018, hoping to leverage Translate Bio's work on new messenger RNA (mRNA) drugs that cause cells to create a specific protein for treating a range of diseases.
Their work has taken on greater urgency with the coronavirus pandemic, as pharma groups race to be the first to offer a vaccine to halt an outbreak that has killed nearly 470,000 people worldwide since December.
In a statement, Sanofi said they have "multiple COVID-19 vaccine candidates" in the works and hope to start a clinical trial with humans in the fourth quarter of this year.
"We believe that adding this mRNA platform to our vaccines development capabilities will help us advance prevention against current and future infectious diseases," said Thomas Triomphe, executive vice president at Sanofi Pasteur, the firm's vaccines unit.
Sanofi CEO Paul Hudson told journalists on Monday that his firm's most promising COVID-19 treatment is "the only vaccine in the race which is offering a proven platform which works at scale."
"We are a little bit slower but we are much more likely to have success," he said at a briefing ahead of Sanofi's investor day Tuesday.
Hudson drew the ire of French officials last month when he suggested that any COVID-19 vaccine would be offered first to the US government, which has invested millions in its development by the company.
Under pressure, he later indicated that it would be available to everyone at the same time and he announced a new 490 million euro vaccine production site in France last week while touring a facility with President Emmanuel Macron.
"We're making vaccines in Europe and we're making vaccines in the US, so we anticipate having vaccines simultaneously available in many markets," Hudson said Monday.
Agence France-Presse
MOSCOW - Russia on Thursday rolled out a drug approved to treat patients suffering from the novel coronavirus, its state financial backer said, as the number of infections there surpassed half a million.
The first deliveries of the new antiviral drug, registered under the name Avifavir, were made to some hospitals and clinics across the country, Russia's RDIF sovereign wealth fund said in a press release.
RDIF has funded trials and has a 50 percent share in the drug's manufacturer ChemRar.
The health ministry gave its approval for the drug's use under a special accelerated process while clinical trials, held over a shorter period and with fewer people than many other countries, were still underway.
There is currently no vaccine for COVID-19, the disease caused by the new coronavirus, and human trials of several existing antiviral drugs have yet to show efficacy.
RDIF chief Kirill Dmitriev last week told Reuters the plan was for ChemRar to manufacture enough of the drug to treat around 60,000 people a month.
Dmitriev on Thursday said more than 10 countries had made requests for Avifavir supplies.
Negotiations were underway to supply the drug to almost all of Russia's regions, with 7 of its more than 80 regions receiving Thursday's initial deliveries, Dmitriev added.
With 502,436 cases, Russia has the third highest number of infections in the world after Brazil and the United States, but has a relatively low official death toll of 6,532 - something that has been the focus of debate.
The Moscow health department on Wednesday raised its death toll for the month of May, citing changes in the way it determines the cause of death for patients suffering from other health problems.
-reuters-
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.
-reuters-
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.
-reuters-
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.
-reuters-
LONDON - British pharmaceuticals group AstraZeneca has partnered with the University of Oxford to develop and distribute a coronavirus vaccine being trialed in the UK, the pair announced Thursday.
Human trials of the vaccine developed by the university's Jenner Institute began last week, with hundreds of people volunteering to be part of the study that has received £20 million ($24.7 million, 22.6 million euros) in government funding.
"The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford," said a joint statement.
"Under the agreement, AstraZeneca would be responsible for development and worldwide manufacturing and distribution of the vaccine."
Data from the first phase trial could be available next month, the statement said.
"Advancement to late-stage trials should take place by the middle of this year," it added.
The news comes after US scientists hailed the results of a major drug trial. People treated with Remdesivir recovered about 30 percent faster than those on a placebo.
Agence France-Presse
WASHINGTON - Gilead Science's remdesivir, one of the most highly anticipated drugs being tested against the new coronavirus, showed positive results in a large-scale US government trial, the company said Wednesday.
"We understand that the trial has met its primary endpoint and that NIAID (National Institute of Allergy and Infectious Diseases) will provide detailed information at an upcoming briefing," the company said.
Though it is difficult to precisely quantify the finding in the absence of results, it represents the first time any drug has been shown to improve outcomes against the COVID-19 illness, which has claimed more than 200,000 lives globally and brought the world economy to a grinding halt.
There have been mixed results for the intravenous antiviral in recent weeks. A summary of results posted on the website of the World Health Organization showed it failed in a smaller Chinese trial, but days before that, Stat reported it had shown significant efficacy at a Chicago hospital.
However, this trial, begun in late February and overseen by the US government, is the largest and technically most robust.
According to a data sheet, its estimated enrollment was 800 patients, a portion of whom received the drug while the rest received a placebo.
Neither the patients nor their physicians were aware of which group they belonged to, in order to eliminate unconscious bias.
It is a Phase 3 trial, the final stage before any medication can receive regulatory approval from the Food and Drug Administration (FDA).
Remdesivir, which previously failed in trials against Ebola, belongs to a class of drugs that act on the virus directly -- as opposed to controlling the abnormal and often lethal autoimmune response it causes.
It mimics 1 of the 4 building blocks of RNA and DNA and gets absorbed into the virus's genome, which in turn stops the pathogen from replicating.
The antimalarial drugs hydroxychloroquine and chloroquine are also being widely used against COVID-19 on a so-called "compassionate basis" pending results from large trials, with early studies decidedly mixed.
Other therapies that are being studied include collecting antibodies from COVID-19 survivors and injecting them in patients, or harvesting antibodies from genetically-engineered mice that were deliberately infected.
Agence France-Presse
LONDON - The world will need more than one COVID-19 vaccine so drug companies must partner in the race to develop the weapons to fight the novel coronavirus, GlaxoSmithKline Chief Executive Officer Emma Walmsley said on Wednesday.
GlaxoSmithKline Plc and Sanofi SA said on Tuesday they would develop a vaccine to fight the fast-spreading coronavirus.
The drugmakers said they expect to start clinical trials for the vaccine in the second half of this year. If successful, the vaccine would be available in the second half of 2021.
Walmsley said GSK's partnership with Sanofi brings scale to the attempt to get a COVID-19 vaccine but that there was still an enormous amount of work to do.
"The world's going to definitely need more than one vaccine when you think about demand in this hugely challenged global health crisis," she told BBC Radio.
The adjuvanted vaccine will be developed by combining Sanofi's S-protein COVID-19 antigen and GSK's pandemic adjuvant technology.
"It normally takes a decade, sometimes even more, to develop a vaccine but obviously we are in an unprecedented situation, the need is incredibly urgent. We are partnering with regulators to try and go as fast as we safely can."
As of April 14, at least 1.97 million people have tested positive for COVID-19, according to a Reuters tally.
-reuters-
SEOUL - Two elderly South Korean coronavirus patients recovered from severe pneumonia after being treated with plasma from survivors, researchers said Tuesday, offering hope in the face of the global pandemic.
Scientists have pointed to the potential benefits of plasma -- a blood fluid -- from recovered individuals who have developed antibodies to the virus enabling the body's defenses to attack it.
Since emerging in China in December, the coronavirus has killed almost 75,000 people as drugmakers worldwide race to develop a vaccine and treatments for the disease.
Plasma therapy could become "an alternative treatment for patients in critical condition who do not respond to antiviral drugs," said Choi Jun-yong, a doctor and researcher at Severance Hospital in Seoul, where both patients were treated.
But large-scale clinical trials were needed to prove its effectiveness, he added.
One of the 2 patients was a 71-year-old man with no underlying conditions who only improved when treated with plasma from a recovered patient in his 20s, along with steroids.
He was initially given malaria drugs and a respirator for severe pneumonia.
The other patient, a 67-year-old female, also did not respond to initial treatments including malaria, HIV drugs, and oxygen therapy. She began to recover after receiving plasma therapy and steroids at the same time, researchers said.
Their findings were published in the peer-reviewed Journal of Korean Medicine.
Kwon Jun-wook, an official at Seoul's Central Disease Control Headquarters, said plasma therapy was "important" when there was "currently no vaccine or treatment available" for the virus.
He called on experts to examine the 2 cases urgently.
Research on plasma and other therapies "will proceed quickly," Kwon added.
Small studies on plasma have demonstrated its effectiveness in treating infectious diseases, including Ebola and SARS.
Trials started in France on Tuesday involving 60 patients in Paris hospitals, half of whom will receive plasma from recovered patients.
The US Food and Drug Administration authorized physicians to experiment with the strategy to fight the coronavirus, and tests are also being carried out in China.
South Korea endured one of the worst early outbreaks of the virus, but appears to have brought it under control thanks to its extensive "trace, test and treat" program.
Agence France-Presse
LONDON - Strains of malaria resistant to two key anti-malarial medicines are becoming more dominant in Vietnam, Laos and northern Thailand after spreading rapidly from Cambodia, scientists warned on Monday.
Using genomic surveillance to track the spread of drug-resistant malaria, the scientists found that the strain, known as KEL1/PLA1, has also evolved and picked up new genetic mutations which may make it yet more resistant to drugs.
"We discovered (it) had spread aggressively, replacing local malaria parasites, and had become the dominant strain in Vietnam, Laos and northeastern Thailand," said Roberto Amato, who worked with a team from Britain's Wellcome Sanger Institute and Oxford University and Thailand's Mahidol University.
Malaria is caused by Plasmodium parasites which are carried by mosquitoes and spread through their blood-sucking bites.
Almost 220 million people were infected with malaria in 2017, according to World Health Organization estimates, and the disease killed 400,000 of them. The vast majority of cases and deaths are among babies and children in sub-Saharan Africa.
Malaria can be successfully treated with medicines if it's caught early enough, but resistance to anti-malarial drugs is growing in many parts of the world, especially in Southeast Asia.
The first-line treatment for malaria in many parts of Asia in the last decade has been a combination of dihydroartemisinin and piperaquine, also known as DHA-PPQ. Researchers found in previous work that a strain of malaria had evolved and spread across Cambodia between 2007 and 2013. This latest research, published in The Lancet Infectious Diseases journal, found it has crossed borders and tightened its grip.
"The speed at which these resistant malaria parasites have spread in Southeast Asia is very worrying," said Olivo Miotto, who co-led the work.
"Other drugs may be effective at the moment but the situation is extremely fragile and this study highlights that urgent action is needed," he said.
source: news.abs-cbn.com
