Unprecedented collaborations involving the biotech industry and government agencies are urgently needed to develop and produce the billions of doses of vaccine that will be needed to stop the coronavirus pandemic, four public-health pioneers declare.
The experts behind the call to action, published today by the journal Science, include Larry Corey, a past president and director of Seattle’s Fred Hutchinson Cancer Research Center and a professor in its vaccine and infectious disease division.
Corey’s co-authors are Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases; John Mascola, director of NIAID’s Vaccine Research Center; and Francis Collins, director of the National Institutes of Health.
Their essay holds up a public-private partnership known as Accelerating COVID-19 Therapeutic Innovations and Vaccines, or ACTIV, as a model for the collaboration that’ll be needed to address the coronavirus challenge.
“We’re experiencing a series of unprecedented events with a disease that has spread globally and infected more people in a shorter time than any other infection in modern times,” Corey said in a news release. “In order to overcome the challenges in front of us, we each need to bring nothing short of our absolute best.”
ACTIV aims to establish a centralized process for conducting harmonized trials of multiple vaccine candidates, with a common board to monitor the trials’ safety and data quality.
“There is an emerging consensus that vaccine trials need to either use common independent laboratories or contribute samples and data for the purpose of generating surrogate markers that ultimately speed licensure and an overall comparison of efficacy,” the four experts write.
The first U.S. clinical trial of a COVID-19 vaccine began in Seattle in mid-March, and takes advantage of a relatively new RNA-based technology. Other vaccine development efforts are ramping up, using a variety of development strategies.
The most commonly mentioned time frame for getting a COVID-19 vaccine approved is a year to 18 months, but during a GeekWire virtual forum last week, Gates Foundation CEO Mark Suzman noted that the timeline could be as short as nine months “if we’re really lucky,” or as long as three years “if we’re unlucky.”
Pursuing multiple vaccines in parallel will improve the odds of getting lucky.
Even the rivals in the vaccine race recognize that they’ll have to join forces. “Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone,” said Mikael Dolsten, Pfizer’s chief scientific officer.
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The authors of today’s essay echo Microsoft co-founder Bill Gates’ view that manufacturing capacity will have to be built up even before vaccines are fully approved for use.
“The ability to manufacture hundreds of millions to billions of doses of vaccine requires the vaccine-manufacturing capacity of the entire world,” they write. “Although new technologies and factories can be developed to sustain production, there is an immediate need to fund the necessary biomanufacturing infrastructure, including the fill/finish steps that provide vialed vaccine products for distribution.”
Because the virus that causes COVID-19 has spread so widely and so rapidly, researchers still have little idea how protective a given vaccine will be over the long term, and what happens when patients who receive the vaccines are re-exposed to the virus. For that reason, they say participants in the early vaccine trials will have to be monitored for a prolonged period of time.
Even if multiple vaccines become available, public health officials will face the challenge of persuading billions of people around the world to get vaccinated — which is becoming an increasingly tall order amid the proliferation of COVID-19 conspiracy theories. Ironically, closer collaboration between government agencies, research groups and vaccine manufacturers could feed those theories.
Corey, a veteran of the fight against the AIDS epidemic of the 1980s, acknowledged that ending the coronavirus outbreak isn’t something even the world’s most seasoned scientific experts can do by themselves.
“Besides scientists and health experts, we need the help of industry and affected communities throughout the country to participate in large-scale trials of potential COVID vaccines,” he said.
