Coronavirus Update: Vaccines Rushing into Clinical Trials

Vaccine

As the coronavirus outbreak that causes COVID-19 escalates, biopharma companies and government agents are working quickly to develop and test a vaccine, although most estimates are it will take 12 to 18 months before it could get to market. As of March 5, 2020, California has declared a state of emergency, several Asian and Middle Eastern countries are restricting travel and the global stock markets are struggling with the uncertainty. The Dow Jones industrial average dropped more than 700 points Thursday morning.

Although China is the hardest-hit country, there are now more than 92,000 cases worldwide with deaths exceeding 3,131. South Korea has confirmed more than 6,000 cases with 40 deaths; Italy has more than 3,000 cases with more than 100 deaths. More than 150 cases are confirmed in the U.S. with 11 deaths.

Inovio Pharmaceuticals has indicated it is accelerating its vaccine timeline with human clinical trials expected to begin in April in the U.S. Inovio was the only company to have a Phase II clinical trial for a vaccine against the coronavirus that caused MERS. The company was also involved in helping during the 2016 Zika virus outbreak and the Ebola outbreak in 2014.

The company stock took a jump of about 12% at the news. The company’s chief executive officer, J. Joseph Kim, said, “We immediately began preclinical testing and small-scale manufacture and have already shared robust preclinical data with our public and private partners. We plan to begin human clinical trials in the U.S. in April and soon thereafter in China and South Korea, where the outbreak is impacting the most people.”

Jason McCarthy, an analyst with Maxim, said he believes Inovio is probably the best company to come out with a vaccine and the speed it developed INO-4800 “is a demonstration of the versatility of speed with which Inovio can respond to an ‘emergency’ situation.”

The company believes it can deliver 1 million doses of the vaccine by the end of the year with existing resources but will need more resources to scale up from that point.

On February 25, Moderna reported it had shipped its first batch of mRNA-1273, its experimental vaccine against the coronavirus to the U.S. National Institute of Allergy and Infectious Diseases (NIAID). As of March 4, it was reported that researchers at Kaiser Permanente Washington Health Research Institute in Seattle that it had begun recruiting healthy Seattle-area volunteers to participate in the trial. They are hoping to enroll 45 adults for the trial.

Although these both represent unusually rapid development and launch of testing of a vaccine, federal health officials and others in the industry have warned that large-scale manufacture and use of the vaccines, if they are successful in the clinical trials, is at least a year away.

Anthony Fauci, director of the NAID said that even if the first Phase I trial is positive, it would require additional testing to validate the vaccine’s safety and effectiveness, which would take at least a year to 18 months to be “fully confident that we would have a vaccine that would be able to protect the American people.”

The Wall Street Journal reported that Lisa Jackson, senior investigator at the institute and lead researcher, said dosing should start in the next few weeks. “That we have a vaccine supply to conduct a trial within a two-month period is pretty much unprecedented.”

The trial will enroll healthy adults ages 18 to 55 who meet specific criteria, which excludes certain health conditions or medications that affect the immune system. Patients in the trial will be paid $100 for each visit and patents who complete all scheduled visits will get a total of $1,100, according to Kaiser Permanente’s website page about recruitment.

Other companies working on vaccines include Johnson & Johnson and Sanofi, with testing expected to start in the next couple of months. J&J announced on February 11 that its Janssen Pharmaceutical Companies will continue expanding its coronavirus vaccine program with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services. The company is also working with collaboration partners to screen its library of antiviral compounds in hopes of identifying potential drugs for the outbreak.

UK-based GlaxoSmithKline stated Monday that it was working with China-based Clover Biopharmaceuticals to develop a vaccine candidate.

“We are proud to contribute to cutting edge research from scientists at Clover Biopharmaceuticals in China as part of our strategy to make our adjuvant technology available to selected partners,” said Thomas Breuer, GSK Vaccines’ chief medical officer.

On February 19, Sanofi’s Sanofi Pasteur, its vaccines business, announced it was collaborating on a vaccine with BARDA as well. It also plans to continue studying an advanced preclinical SARS vaccine candidate it had worked on during the 2002-2003 SARS outbreaks. Severe acute respiratory syndrome (SARS) is caused by a coronavirus that has some similarities to the COVID-19 virus. The SARS virus mostly disappeared by 2004. Sanofi plans to leverage its recombinant DNA platform to produce a vaccine candidate to the new coronavirus.

Industry efforts globally to develop vaccines or to test known antivirals against the coronavirus have been extensive and aggressive.

On March 4, Japanese drugmaker Takeda Pharmaceutical Co. indicated it was attempting to develop a drug based on the blood of patients who recovered from COVID-19. The thinking is that antibodies culled from the patients could boost the immune systems of new patients, attacking the disease.

Vir Biotechnology and Alnylam Pharmaceuticals also announced on March 4 they were expanding their existing collaboration to include RNAi therapeutics targeting SARS-CoV-2, the virus that causes COVID-19. They plan to leverage Anlylam’s advances in lung delivery of novel siRNA conjugates with Vir’s infectious disease expertise. Alnylam recently identified siRNA targets in highly conserved regions of the coronavirus RNAs.

In late February, Gilead Sciences announced it was launching two Phase III clinical trials of its investigational antiviral drug remdesivir in adults diagnosed with COVID-19.

Gilead’s trials will evaluate two dosing durations of the drug, which is given intravenously. The randomized, open-label, multicenter studies will enroll about 1,000 patients mostly in Asia, as well as in countries that have had high numbers of diagnosed cases. The trials are planned to start in March.

These trials are on top of two clinical trials in China’s Hubei province led by the China-Japan Friendship Hospital and a recently launched trial in the U.S. led by NIAID. Gilead donated the drug and provided scientific expertise for those trials. The China trial data is expected in April.

It has been reported, and as some of the stories about SARS and MERS suggest, there was earlier work on vaccines against deadly strains of coronavirus. One recent story is of Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital and Dean of the National School of Tropical Medicine at the Baylor College of Medicine in Houston, who were working in 2016 on a vaccine but couldn’t get anyone interested in investing in the research.

“We tried like heck to see if we could get investors or grants to move this into the clinic,” Hotez told NBC. “But we just could not generate much interest.”

Hotez and others who work on vaccine development believe that SARS and MERS should have resulted in significant federal and global investments into vaccine development against future coronavirus epidemics. That didn’t happen and Hotez’s experimental vaccine is waiting in a freezer with no commercial production or investment in sight.

“We could have had this ready to go and been testing the vaccine’s efficacy at the start of this new outbreak in China,” Hotez said. “There is a problem with the ecosystem in vaccine development, and we’ve got to fix this.”

Hotez is speaking before the House Committee on Science, Space and Technology today, arguing that if anything, this new coronavirus outbreak should stimulate change in how the government funds vaccine development.

“It’s tragic that we won’t have a vaccine ready for this epidemic,” Hotez wrote in prepared remarks. “Practically speaking, we’ll be fighting these outbreaks with one hand tied behind our backs.”

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