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Worldwide COVID-19 Vaccine Development – A Regulatory Perspective.

The race against time to find a vaccine for the new, deadly coronavirus is well underway. Currently, over 170 candidate vaccines are being followed by the World Health Organization in an attempt to find a viable vaccine in a short span of time. While the Governments and researchers across the world are sprinting to develop a vaccine for the novel coronavirus, here, we summarize the latest information on worldwide COVID-19 vaccine development from a regulatory perspective.

A standard vaccine development takes a minimum of 10 years. But researchers worldwide are working around the clock to ensure a fast-tracked vaccine development process that could speed up a successful candidate to market in approximately 12-18 months.

More than 150 coronavirus vaccines are in development across the world—and hopes are high to bring one to market in record time to ease the global crisis. Several efforts are underway to help make that possible, including the U.S. government’s Operation Warp Speed (OWS) initiative, which has pledged $10 billion and aims to develop and deliver 300 million doses of a safe, effective coronavirus vaccine by January 2021. The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021.

To date, just one coronavirus vaccine has been approved. Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamaleya Research Institute in Moscow – was approved by the Ministry of Health of the Russian Federation on 11 August. Experts have raised considerable concern about the vaccine’s safety and efficacy given it has not yet entered Phase 3 clinical trials.[2]

The COVAX initiative, part of the World Health Organization’s (WHO) Access to COVID-19 Tools (ACT) Accelerator, is being spearheaded by the Coalition for Epidemic Preparedness Innovations (CEPI); Gavi, the Vaccine Alliance; and WHO. The goal is to work with vaccine manufacturers to offer low-cost COVID-19 vaccines to countries. Currently, CEPI’s candidates from companies Inovio, Moderna, CureVac, Institut Pasteur/ Merck/ Themis, AstraZeneca/ University of Oxford, Novavax, University of Hong Kong, Clover Biopharmaceuticals, and University of Queensland/CSL are part of the COVAX initiative. There are further candidates being evaluated in the COVAX Facility from the United States and internationally.

Within OWS, the US National Institutes of Health (NIH) has partnered with more than 18 biopharmaceutical companies to accelerate development of drug and vaccine candidates for COVID-19 (ACTIV). The COVID-19 Prevention Trials Network (COVPN) has also been established, which combines clinical trial networks funded by the National Institute of Allergy and Infectious Diseases (NIAID): the HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network (HPTN), Infectious Diseases Clinical Research Consortium (IDCRC), and the AIDS Clinical Trials Group.

Members of ACTIV have suggested developing safe controlled human infection models (CHIMs) for human trials could take 1-2 years. A sponsor would need to provide data from placebo-controlled trials indicating their vaccine is at least 50% effective against COVID-19 in order to be authorized for use, according to FDA guidance issued and effective 30 June. Additional FDA guidance on COVID-19 vaccine EUAs was released 06 October. The guidance calls for interim analysis based on a clinical endpoint in a Phase 3 trial of at least 2 months in over 3,000 participants, as well as relevant safety and efficacy data from Phase 1 and Phase 2 trials.

Given the urgent need, some vaccine developers are compressing the clinical process for SARS-CoV-2 by running trial phases simultaneously. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (USA), has stated that independent Data and Safety Monitoring Boards can end trials early if their interim results are overwhelmingly positive or negative. Meanwhile, the Trump Administration has pressured the U.S. Food and Drug Administration to quickly approve a vaccine and is pushing states to establish vaccine distribution sites by November 1, 2020. Some observers worry these decisions are politically motivated, because the deadline falls just days before the U.S. presidential election.

While the FDA has agreed to expedite the approval process, on October 6 the independent federal agency released more stringent safety standards—initially opposed by the White House—that make it highly unlikely for a vaccine to be cleared by Election Day. Centre for Disease Control (CDC) director Robert Redfield, vaccine developers, and the FDA have also said it’s unlikely a vaccine will be widely available until the middle of 2021.

The dilemma doesn’t end here. Even after a vaccine is approved, it faces potential roadblocks when it comes to scaling up production and distribution, which also includes deciding which populations should get it first—and at what cost. Many vaccines also stay in what’s called phase four, a perpetual stage of regular study.

Some useful links to know the worldwide status of COVID-19 vaccine candidates are given below:

  1. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
  2. https://thevaccinetracker.com/

References:

  1. https://www.nationalgeographic.com/science/health-and-human-body/human-diseases/coronavirus-vaccine-tracker-how-they-work-latest-developments-cvd/
  2. https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-vaccine-tracker
  3. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/development-and-licensure-vaccines-prevent-covid-19

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