Researchers scramble to meet ‘urgent need’ for COVID-19 vaccine
As deaths from COVID-19 increase to more than 100,000 in the United States, institutions around the world are working to develop an effective vaccine. Kaiser Permanente Washington Health Research Institute in Seattle is conducting a phase 1 clinical trial to assess an investigational vaccine, while Johnson & Johnson plans to initiate human clinical studies for its potential candidate by September.
According to WHO, there are 10 COVID-19 vaccine candidates under clinical evaluation and an additional 115 candidates in preclinical evaluation. In a remote hearing of the U.S. Senate Committee on Health, Education, Labor & Pensions earlier this month, Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said an NIH-directed trial is expected to enter phase 2/3 in late spring or early summer. AstraZenenca is currently working with the University of Oxford to make the institution’s vaccine widely available around the world, with initial deliveries expected in September.
Another effort comes from researchers at Cincinnati Children’s Hospital, who are attempting to use nanosized pieces of the SARS-CoV-2 pseudovirus as a vaccine candidate for COVID-19.
“While the ongoing COVID-19 pandemic continues to claim more lives each day, there are no effective vaccines or antivirals available against this deadly illness,” Ming Tan, PhD, assistant professor in the division of infectious diseases, department of pediatrics, at Cincinnati Children’s Hospital Medical Center, told Healio. “We therefore set off to apply our recently invented technology to meet this urgent need.”
According to Tan, researchers plan to produce protein nanoparticles that mimic the inner shell of a norovirus capsid. The nanoparticle can be used to highlight the spike proteins from other viruses, making it a potential vaccine candidate.
Tan noted that, in general, vaccine development is “highly time-consuming and costly.” Both of these factors are affecting the development of their vaccine, he added.
The researchers are currently producing the vaccine ingredients. The next step will evaluate the vaccine’s efficacy in animal models, followed by efforts to establish the vaccine’s safety and efficacy in humans through clinical trials. Tan expects the process will take approximately 2 and a half years, assuming the required funding for the project is available. The vaccine ingredients should be completed within a few months.
“Vaccines remain the most effective approach against infectious diseases. Our technology provides a fast way to develop a COVID-19 vaccine that will induce COVID-19-specific antibodies that can inhibit COVID-19 viral infection, with reduced manufacturing time and cost,” Tan said. “In addition, because our vaccine does not involve a real COVID-19 virus, it is safer than the traditional vaccine approaches that rely on live COVID-19 viruses.”
Meanwhile, Novavax began enrolling participants earlier this week in a phase 1/2 clinical trial of NVX-CoV2373, its COVID-19 vaccine candidate.
“Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer [to] addressing the fundamental need for a vaccine in the fight against the global COVID-19 pandemic,” Stanley C. Erck, President and CEO of Novavax, said in a press release. “We look forward to sharing the clinical results in July and, if promising, quickly initiating the phase 2 portion of the trial.”
NVX-CoV2373’s Matrix-M adjuvant stimulates neutralizing antibodies and improves immune responses. Phase 1 will be a randomized, observer-blinded, placebo-controlled trial to determine the safety and immunogenicity of the candidate with and without the Matrix-M adjuvant. Phase 2 will be conducted in multiple countries, including the United States, and will evaluate safety, immunity and disease reduction in a broad age range. Researchers hope to have preliminary results from the first phase of the trial by July of this year.
The goal for researchers at Cincinnati Children’s Hospital Medical Center is to develop a vaccine “with the best cost-effectiveness to control and prevent future occurrences of COVID-19, whether that’s another pandemic or outbreak,” Tan said.
Other experts are less optimistic about vaccine capabilities. During a Reuters virtual press conference, William Haseltine, PhD, chair and president of Access Health International, noted that the world should prepare for the possibility that a vaccine is never developed, comparing the current rush to develop a COVID-19 vaccine with efforts to develop an HIV vaccine in the 1980s.
“I can say with the same kind of conviction — it’s not that we won’t have a vaccine, but we don’t know for sure,” Haseltine said. “Do not count on it. Don’t listen to the politicians who say, ‘We are going to have one by the time my re-election comes around.’”
Haseltine also noted that global cooperation is essential to maximize the potential for an effective vaccine.
“This should not be considered to be a race,” he said. “We are sharing information as fast as we can with scientists all over the world.” – by Eamon Dreisbach
AstraZeneca. AstraZeneca advances response to global COVID-19 challenge as it receives first commitments for Oxford’s potential new vaccine. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/astrazeneca-advances-response-to-global-covid-19-challenge-as-it-receives-first-commitments-for-oxfords-potential-new-vaccine.html. Accessed May 28, 2020.
WHO. Draft landscape of COVID-19 candidate vaccines. https://www.who.int/who-documents-detail/draft-landscape-of-covid-19-candidate-vaccines. Accessed May 27, 2020.
WHO. Situation Report – 128. https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200527-covid-19-sitrep-128.pdf?sfvrsn=11720c0a_2. Accessed May 28, 2020.
Disclosures: Erck is president and CEO of Novavax. Haseltine is chair of Access Health International. Tan reports that the vaccine project is funded by Cincinnati Children’s Hospital Medical Center’s COVID-19 research innovation and pilot funding.