In the global hunt for vaccines to combat coronavirus, Indian companies are now pitching in. After Ahmedabad-based Zydus Cadila and Pune-based Serum Institute, now Hyderabad-based Bharat Biotech has joined the race.
Bharat Biotech and the US-based FluGen along with virologists at the University of Wisconsin-Madison have begun the development and testing of a unique vaccine against covid-19 called CoroFlu. Speaking to Business Today, Chairman and Managing Director of Bharat Biotech Krishna M Ella said a lot depends on the approval process. "If the government acts fast on it and treats it as a national emergency, it should be possible to get the vaccine out in about eight months."
However, experts say, the process is such that a new vaccine launch may take at least one to two years. For instance, the development involves undertaking animal studies (on two species as per Indian regulations), then getting the permission from the Drug Control General of India (DCGI) to make batches for phase I studies and these batches in turn need to be certified by the Central Drugs Laboratory (CDL), Kasauli for human use in India. Then comes the phase 2 (the dosing studies) and the phase 3 (the immunogenicity or the ability to trigger an immune response in the body/and the efficacy of the vaccine) development of the vaccine.
However, global experts estimate a much longer time period. "It could take anywhere between a year to 18 months for a vaccine to be ready," Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, US remarked to the media.
However, Ella believes the process could be faster in India as CoroFlu is being built on the backbone of FluGen's flu vaccine candidate known as M2SR. "M2SR is proven in phase 2 human challenge studies, so it can fastrack the project," he said.
"Based on an invention by UW-Madison virologists and FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann, M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu. Kawaoka's lab will insert gene sequences from SARS-CoV-2, the novel coronavirus that causes the disease COVID-19, into M2SR so that the new vaccine will also induce immunity against the coronavirus," says a note issued by University of Wisconsin-Madison and by Bharat Biotech.
FluGen will transfer its existing manufacturing processes to Bharat Biotech to enable the company to scale up production and produce the vaccine for clinical trials. Bharat Biotech will manufacture the vaccine, conduct clinical trials and prepare to produce the vaccine for global distribution. The company can produce almost 300 million doses per year, the note says.
Refinement of the CoroFlu vaccine concept and testing in laboratory animal models at UW-Madison is expected to take three to six months. It also says that Bharat Biotech will then begin production scale-up for safety and efficacy testing in humans. "CoroFlu could be in human clinical trials by the fall of 2020."
Four Phase I and Phase II clinical trials involving hundreds of subjects have shown the M2SR flu vaccine to be safe and well tolerated. Thus, M2SR's ability to induce a strong immune response, and the ability of influenza viruses to carry sequences of other viruses make it an attractive option for rapidly developing CoroFlu as a safe and effective SARS-CoV-2 vaccine.
"We are going to modify M2SR by adding part of the coding region for the coronavirus spike protein that the virus uses to latch onto cells and begin infection," says Neumann, a senior virologist in Kawaoka's lab and co-founder of FluGen.
"CoroFlu will also express the influenza virus hemagglutinin protein, which is the major influenza virus antigen, so we should get immune responses to both coronavirus and influenza," he adds.
M2SR has been described as a unique form of the flu virus. It lacks a gene called M2, which restricts the virus to undergoing only a single round of replication in cells.
"The single replication means the virus can enter the cell, but it can't leave," explains FluGen co-founder, president and CEO Paul Radspinner in a note. "In essence it tricks the body into thinking it's infected with flu, which triggers a full immune response. But since it can't replicate further, you don't get sick."
CoroFlu, like M2SR will be delivered intranasally. This route of administration mimics the natural route of infection by coronavirus and influenza and activates several modes of the immune system. Intranasal delivery is more effective at inducing multiple types of immune responses than the intramuscular shots that deliver most flu vaccines.
M2SR was developed by FluGen and includes technology exclusively licensed through the Wisconsin Alumni Research Foundation (WARF), which manages patents for UW-Madison.