Coronavirus crisis puts vaccine trials on the fast track

New Delhi: Extraordinary times require extraordinary responses.

The deadly health crisis caused by covid-19 has set off a frenetic race against time to develop a vaccine, with progress being made way faster than any previous effort.

While 83 companies across the globe are vying to develop a vaccine, six have already advanced to human trials or clinical evaluation stage, with 77 in pre-clinical evaluation phase as on 23 April, according to the World Health Organization (WHO) database.

That’s an unprecedented pace. The mumps vaccine—the fastest to ever reach the markets—took four years to licensing in 1967, according to National Geographic.

Zydus Cadila, Serum Institute of India, Biological E, Bharat Biotech, Indian Immunologicals Ltd, and Mynvax are among local companies trying to develop a vaccine for covid-19.

In line with the swift global response to develop a vaccine for covid-19, the Drug Controller General of India (DGCI) has tweaked its Clinical Trial Rules 2019, saying it will waive off clinical trials on people in India and approve any drug or vaccine for covid-19 that is approved in any other country.

However, according to the DGCI regulations, newer drugs can only be approved, from the US, Japan, Australia, Canada and European Union, if they have included patients of Indian origin in their studies.

“Due to an emergency situation arising out of the pandemic, if any drug or vaccine gets approved by any drug regulatory agency of any country for covid-19 after ensuring its safety and efficacy, we will approve it through accelerated mechanism by waving off clinical trials on Indian population on a case-by-case basis," a senior official in DGCI said on condition of anonymity.

The regulator hasn’t received any such application to conduct clinical trials, the official said. DGCI has so far approved three applications related to covid-19, comprising Serum Institute of India, which is working on a preventive vaccine, Zydus Cadila’s candidate for immune response for three trials and Biocon for testing kits.

The normal timeframe for developing a vaccine ranges from 10 to 15 years but it is likely that the covid-19 vaccine will be available in about a year with several firms joining forces to fast-track efforts to develop a vaccine for the deadly disease.

China’s CanSino Biological Inc./Beijing Institute of Biotechnology, Beijing Institute of Biological Products/Wuhan Institute of Biological Products, Sinovac, US-based Inovio Pharmaceuticals, Moderna/NIAID and University of Oxford, UK, have already entered the human trial phase of their vaccines.

“The world has seen many diseases emerge before but covid-19 has been different due to which there is a fast response for vaccine," said Dr. Gagandeep Kang, head of the Indian Council of Medical Research (ICMR) task force on covid-19 vaccines.

“H1N1 was a pandemic but there was H1N1 many years ago, so some partial protection may have been there and the disease was relatively mild," Dr. Kang said, adding that covid-19 deaths and cases will increase until we have drugs for treatment or vaccines for prevention.

Explaining the reasons why a vaccine may be ready by end-2021, experts said that as covid-19 is caused by coronaviruses that are also responsible for other respiratory diseases such as Middle East respiratory syndrome (Mers) and severe acute respiratory syndrome (Sars), companies were already working on vaccines for these diseases. “For development of vaccines, you need funding, knowhow, capacity, vaccine candidates, partnerships. There has been some work already done in efforts to develop a Sars-CoV-2 and Mers-CoV vaccines which were caused by other coronaviruses. Due to this, covid-19 could be fast tracked," said Dr. Naveen Thacker, a former member of GAVI Board, the Vaccine Alliance is a public–private global health partnership committed to increasing access to immunization in poor countries.

Soon after the novel coronavirus outbreak, China shared the sequence of the genetic material of Sars-CoV-2 (covid-19) that could pave the way for developing a vaccine for covid-19. Dr. Sanjay Mehendale, member of National Biopharma Mission’s scientific advisory group on covid-19 research and co-chair of clinical trials network group said it was realized that Sars-CoV-2 (Covid-19) shares 79% of its genetic material with the coronavirus responsible for Sars, and 50% with the coronavirus responsible for Mers.

“The biotechnology company, Moderna made a big progress on covid-19 vaccine because they had done a lot of work on Mers vaccine earlier. A fast-track approach using the platform developed for Mers vaccines was used. Moderna’s covid-19 vaccine is already in Phase I human trial as of last week," said Mehendale who maintained that vaccine development otherwise has always been a tough and arduous task, typically requiring 10 to 15 years.

The covid-19 vaccine also seems to follow the path of Ebola vaccine, the pandemic caused by Ebola virus first identified in 1976 with a fatality rate of 50%. The vaccine for Ebola was developed during the West Africa Ebola epidemic of 2014-2016, during which more than 11,000 people died. The vaccine was used under an “expanded access" protocol within a year of development in the Democratic Republic of Congo before regulatory approvals. On 12 November 2019, WHO prequalified an Ebola vaccine. This is the fastest vaccine prequalification process ever conducted by WHO by reviewing safety and efficacy data as the information became available and participating in evaluation process by European regulators (EMA).

“During Ebola, we approved the usage of vaccines even under human trials to be used in patients due to the high mortality rate," said Thacker. A senior DGCI official said considering the damage caused by covid-19, even Phase-1 vaccines, showing some efficacy can be approved either in India or from any other country like the Ebola vaccine.

In the case of tuberculosis (TB), the world’s deadliest infectious disease, with 1.6 million deaths and 10 million new cases in 2017, recently saw a vaccine that has been under development for more than two decades show promising results but may take another decade to be available commercially. The development and licensure of the first dengue vaccine spanned more than 20 years although a safe universal vaccine is still awaited.

“In spite of ongoing work on malaria, tuberculosis and leprosy vaccines, we have still not succeeded. In pandemic scenarios, traditional vaccine development pathway of 10 years could undergo drastic shortening of timescale in case of newer vaccine development," Mehendale said.

Although a vaccine for covid-19 may be available within a year, scientists cautioned that safety and efficacy issues due to continuous mutation of the virus should not be ignored. “Even after the vaccine becomes available, data will have to be generated on whether the vaccine is effective in all populations and if it is effective against different strains of the novel coronavirus, which might start mutating as time passes," Mehendale said.