Why you should care
Because vaccine production needs to move at the speed of the virus.
The U.S. physician spearheading international efforts to find a vaccine against the deadly new strain of coronavirus said he was aiming to begin clinical trials within 16 weeks.
The race is on to halt the highly infectious disease that is spreading across China and other countries. For Richard Hatchett, head of the Coalition for Epidemic Preparedness Innovations, this is the first big test of CEPI’s mission to develop vaccines to combat future epidemics. Oslo-based CEPI, set up three years ago with a $1 billion budget target, is a partnership of governments, industry and charities.
“We are moving with unprecedented speed,” said Hatchett, a former chief medical officer at the U.S. agency that protects Americans against pandemics and biological weapons. “This is the first new epidemic disease of note to emerge since CEPI’s founding,” added Hatchett, a member of the homeland and national security teams under presidents George W. Bush and Barack Obama.
In the short time since the novel coronavirus (nCoV) was detected in a teeming live animal market in the city of Wuhan, CEPI has moved to select two U.S. biotechnology groups and the University of Queensland in Australia to lead the vaccine hunt. A fourth partnership is imminent.
The world in the 21st century needs this type of public-private partnership where each of the actors in this vaccine emergency … has a role to play.
Jean Lang, Sanofi Pasteur
The idea is to repurpose existing genetic technology to create a new breed of vaccines. Underlining the urgency, the partnership with one company, Boston-based Moderna, was hammered out in 48 hours.
“We had already done a deep evaluation of Moderna’s technology so we could move very quickly,” Hatchett said. “I had my first conversation with their chief executive Stéphane [Bancel] on Monday, and the contract was signed on Wednesday.”
CEPI said it aimed to have at least one candidate to prevent infection of the coronavirus ready for safety testing on humans in phase-one clinical trials within 16 weeks.
The last time a vaccine was developed at such breakneck speed in the face of an emerging epidemic was six years ago, as a deadly Ebola outbreak raged across West Africa. A consortium of government agencies, charities and companies supported the project, which rushed an Ebola vaccine into safety trials in volunteers in October 2014.
Clinical trials in Guinea began five months later, just as the epidemic was waning, but it came in time to prove the vaccine’s effectiveness in preventing infection. That vaccine, manufactured by Merck of the U.S., saved many lives during last year’s Ebola outbreak in the Democratic Republic of Congo, when 236,000 people were vaccinated, including 60,000 health and frontline workers.
A conventional vaccine consists of an inactivated virus or its constituent proteins. This trains the immune system to recognize the pathogen and produce protective antibodies against it, if it encounters the real virus in future.
The newer vaccines inject genetic material — DNA or messenger RNA — into human cells with the instructions to produce proteins identical to those from the virus, which again primes the immune system to fight off the disease. By employing mRNA technology, Moderna hopes to produce a viable nCoV candidate vaccine for testing within months.
Among the big pharmaceutical groups, efforts are being led by Johnson & Johnson, which is employing technology similar to that used to produce another Ebola vaccine. Merck and Sanofi are monitoring the situation and lending expertise.
In China, a company called Clover Biopharmaceuticals has ambitious plans to have a potential candidate ready for testing within just a few weeks by developing a vaccine based on key proteins within the coronavirus.
Underlining the global nature of the push, Russian and Chinese scientists are to team up to jointly develop a coronavirus vaccine. Jack Ma, the founder of Alibaba and China’s richest man, has donated 100 million renminbi ($14 million), of which 40 million will be dedicated to Chinese efforts to create a vaccine.
The vaccine quest has been aided by the Beijing authorities’ decision to publish details of the coronavirus as soon as possible, enabling academics and drug companies around the world to study its genome sequence.
But scientists have cautioned that even if they are able to speed up the early stage development, the need for rigorous clinical trials and manufacturing challenges mean a vaccine will not be ready for use worldwide in much less than a year.
“All these time lines are aggressive and aspirational,” said Hatchett. “As circumstances unfold, there may be opportunities to reduce the timing, but it is critically important that any new vaccine is safe and effective.”
Johnson & Johnson expects a vaccine to test in humans within eight to 12 months. “Many years ago, it would have taken five to 10 years,” said Paul Stoffels, Johnson & Johnson chief scientist.
The Queensland research team hopes to have up to 60 volunteers on which to test their vaccine, which UQ Professor Paul Young said would come in the form of a “very safe” non-infectious synthetic protein. Young said their patented molecular clamp vaccine technology would mean “you can plug in new sequence information as it emerges and develop vaccines more rapidly.”
Tom Inglesby, director of the Center for Health Security at Johns Hopkins Bloomberg School of Public Health, praised the funding from groups such as CEPI which made it easier for small companies and academics to develop “promising ideas.” But he added that many would still need to rely on big pharma because of their expertise in clinical trials, regulatory processes and manufacturing.
Jean Lang, head of R&D global health and partnerships at Sanofi Pasteur, the vaccines division of the French drugs group, said these efforts could prove a game-changer in how to respond rapidly and effectively to a health emergency.
“The world in the 21st century needs this type of public-private partnership where each of the actors in this vaccine emergency … has a role to play,” he said.
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