Inovio Pharmaceuticals Inc., which has not yet shared the results of the phase 1 trial for its COVID-19 vaccine candidate, has already received millions of dollars in funding to expand manufacturing capacity.
An announcement Tuesday that the Defense Department would pay $ 71 million to finance the manufacture of a device used to administer the INOvio INO,
The vaccine sent the company’s stock surge higher, to close at a record $ 21.57. Inovio is expected to release Phase 1 data in the coming week.
“The response to the pandemic is different,” said Joseph Kim, CEO of Inovio Pharmaceuticals Inc., which has said it plans to have millions of doses of its candidate vaccine by the end of this year. “We are doing all of these things in parallel.”
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In many ways, the COVID-19 pandemic has disrupted the traditional process of drug development, and now health officials and drug manufacturers are trying to speed up the time it takes to find a vaccine that works, in part moving forward with manufacturing plans even before vaccine candidates. demonstrate its safety or efficacy.
Making this kind of change is what allows government officials like Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, to repeatedly say that it is possible to have a viable COVID-19 vaccine within a year after the Coronavirus First Arrives Attention of the United States Government. Trump administration officials have said they intend to have a vaccine in January as part of Operation Warp Speed.
“Although the safety and efficacy of a vaccine can never be guaranteed until it is actually tested in the field, we feel cautiously optimistic based on the concerted effort and the fact that we are taking financial risks,” Fauci stated during a Hearing Committee. of Energy and Commerce on Tuesday, “not security risks, not science integrity risks, but financial risks in order to be at the forefront of the game.”
A COVID-19 vaccine would change the trajectory of the pandemic, which sickened more than nine million people and killed nearly 500,000, allowing economies to completely reopen and people to return to work and school.
This may be the reason why government officials have said time and time again that a one-year deadline is possible to develop a vaccine that works. “I think we are going to have it very soon,” President Donald Trump said Wednesday at a press conference. But even PhRMA, the pharmaceutical industry’s largest lobbying group, says the vaccine has taken 10 years to develop, and the chief executives of Novartis NVS,
and Johnson & Johnson JNJ,
I have said that developing a COVID-19 vaccine will take more than 12 months.
At the same time, several companies developing COVID-19 vaccines have promised millions and sometimes billions of doses of vaccines that have yet to be proven effective.
This type of guarantee has worried some in the medical community.
“It is the timeline that has been promised,” said Bunny Ellerin, director of the Columbia Business School healthcare and pharmaceutical management program. “Expectations have been set with the public now.”
“There is immense public and political pressure to develop a new vaccine, a process that generally takes years, not months,” wrote three NYU Langone Health medical experts in an opinion piece in JAMA last month. “Moving step-by-step through the phases of clinical trials is the ethical standard for research involving human research participants.”
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However, some pharmaceutical officials and executives have said that developing manufacturing capacity before clinical trials conclude may mean that it is possible to secure and dispense a vaccine that works more quickly, and to supply larger clinical trials that will require thousands of participants. . the line.
According to the World Health Organization, there are 16 candidate vaccines in clinical trials worldwide, four of which are being tested in the US. USA Those are MRNA from Moderna Inc.,
MRNA-1273, INO-4800 from Inovio, NVAX from Novavax Inc.,
NVX-CoV2373 and BioNTech BNTX,
and the PFE from Pfizer Inc.,
At least half a dozen other companies, including Johnson & Johnson, ImmunityBio Inc. and NantKwest Inc. NK,
and Sanofi SNY,
They plan to test their investigational vaccines in the United States if candidates move beyond the preclinical stage.
Much of the development activity is conducted in parallel, and the phases of clinical trials overlap with manufacturing plans, according to Clement Lewin, head of the Sanofi Advanced Biomedical Research and Development Authority (BARDA) office. “It will take a vaccine to get back to normal,” he said. “It makes sense to invest in risk.”
Some relatively unknown companies that help make pharmaceuticals have emerged as pandemic favorites. Emergent BioSolutions Inc. EBS,
who has said he is doing vaccine manufacturing work for AstraZeneca AZN,
J&J, Novavax and Vaxart Inc. VXRT,
has seen stocks jump 36% this year. It has also signed a $ 628 million agreement with US health officials. USA To produce COVID-19 vaccine candidates through 2021. Lonza Group LONN shares,
Moderna’s manufacturing partner for its vaccine candidate COVID-19 has shot up 43% so far this year.
“People, companies are starting to plan to do doses even earlier, you know, the vaccine works,” Fauci said Tuesday during the House hearing. “So the speed risk is not a security risk. It is not a risk to scientific integrity. It’s a risk to money. “
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Still, all of this does not guarantee that these vaccines will work. The race to develop any vaccine is an uphill battle: it is notoriously difficult (“The safety bar is much higher” for vaccines because they are administered to healthy people, said biotech analyst at Mizuho Securities Difei Yang), traditionally has Taken Years, and Once – Promising candidates may not be safe or effective in clinical trials.
It took researchers a year and a half to develop a Zika virus, four years for a mumps vaccine, more than five years for an Ebola vaccine, and 10 years for a flu vaccine. Vaccines against HIV, herpes, and hepatitis C have failed, some in phase 3 trials. And, in some cases, experimental vaccines for SARS and dengue have triggered an improved version of the disease in people who have been vaccinated.
That said, Bernstein analysts are optimistic that this virus is likely to be susceptible to a vaccine. Its foundation? This coronavirus has not mutated much, convalescent serum indicates that some patients develop immunity, and we have not seen significant spikes in reinfections. “While we are optimistic about the eventual development of SARS-CoV-2 vaccines, we would not expect the initial vaccine culture to be silver bullets that will solve the pandemic,” they wrote in a June 5 note to investors.