2021: A New Year of Hope!

By Kiran Mazumdar Shaw, Executive Chairperson, Biocon

As 2020 draws to a close amid news of a second wave of COVID-19 cases and the emergence of a mutant strain of the novel coronavirus in many parts of the world, there is hope yet that 2021 will be a better year for humanity. 

Some silver linings are already visible. With vaccines becoming available, there is hope that our lives can return to a semblance of normalcy in 2021. Beyond vaccines, we could see the discovery of potential treatments for COVID-19 complications, faster and more accurate diagnostic tests for the virus, streamlined regulatory responses to health emergencies, as well as, greater collaboration among scientists globally.

Vaccines: Faster and better

The high level of effectiveness reported for Pfizer’s and Moderna’s mRNA-based vaccines has been a Eureka moment for pandemic science, proving that messenger RNA (mRNA) vaccines that can be manufactured rapidly at low cost are successful in producing robust immunity.

The mRNA platform has shrunk vaccine development timelines from the usual 10 years to a mere 10 months. Moreover, mRNA vaccines are much easier to tweak than conventional vaccines. mRNAs could become the default platform for vaccines going ahead, providing an effective solution for mass vaccination and marking a huge breakthrough in disease prevention.

Single-dose, nasal vaccines could also become available for mass immunisation. Far easier to deliver than intra-muscular injections, intra-nasal vaccines can prove to be a game-changer. These vaccines will eliminate the risk of needle-borne infections like Hepatitis C and HIV, which can cause a bigger health catastrophe than COVID-19.

New testing methods

Cheap, rapid, do-it-yourself (DIY) tests for COVID-19 can be a valuable tool to help reduce disease spread. Unlike laboratory-based RT-PCR tests, some antigen tests can be done affordably within minutes with portable devices. More than 80 such rapid tests are reportedly in the development pipeline.

Rapid COVID-19 tests will allow corporates, academic institutions and entertainment venues to routinely and rapidly screen for infections. While confirmation of positive results may still require a more accurate RT-PCR test, quick home tests can help save lives.

Regulatory agility

The success of Operation Warp Speed in driving vaccine development in the U.S. is pointing to a paradigm change in the regulation of pharma research and innovation. It has shown that the drug development process can be accelerated substantially without compromising on safety.

In the race to save lives, national health regulators like the U.S. FDA have issued Emergency Use Authorisations (EUAs) to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat or prevent COVID-19 in the absence of adequate, approved and available alternatives. Under this stage-gated approach, regulators are issuing a EUA after considering safety and efficacy data and giving final approval only when there is enough real world data related to durability of response, long term safety etc.

To fast-track the development of treatments and vaccines against COVID-19, some regulators have allowed Phase 1, Phase 2 and Phase 3 clinical trials to be conducted in parallel.

If regulators worldwide can take a risk-based approach during a health crisis like COVID-19, they can do it for diseases such as malaria, tuberculosis and pneumonia, which together kill millions of people a year. It will accelerate the journey of much-needed therapies from bench to bedside.

A more resilient India

Protecting a billion-plus population from a pandemic in a country that traditionally spends insufficiently on science was never going to be easy. Yet, India proved itself resilient, resourceful and proactive. India’s government, industry and academia worked overtime and in tandem to come up with innovative solutions to both big and small problems across a range of bio-medical fields: From mathematical models to mass production of masks and personal protective equipment, test kits to treatment modalities, vaccines to ventilators. On the vaccines front, India is being acknowledged as a key global production hub as it boasts the largest vaccines manufacturing capacities in the world. India will mass-produce the Oxford University-AstraZeneca, Novavax and Gamaleya Research Institute vaccines.

A successful COVID-19 vaccination program by leveraging digital technology to drive efficiency and speed will give a huge confidence boost to India’s ailing public healthcare delivery system, setting us up for success in the years ahead.

Greater scientific collaboration

The COVID-19 pandemic has nudged the international scientific community to adopt a collaborative research culture. Scientists have fostered cross-border collaborations and pooled complementary skillsets to hunt promising leads for COVID-19 vaccines and drugs. These symbiotic partnerships have lowered innovation costs, maximized efficiencies and expedited development.

In 2021, collaboration could well become the ‘new normal’ as diverse players join hands to enable effective, concerted action through meaningful partnerships.

Increased focus on infectious diseases

Before the novel coronavirus struck, infectious diseases were perceived as a Third World problem as the wealthier, industrially-advanced North was thought to have almost completely eradicated them.

COVID-19 has triggered a massive reallocation of resources to finding solutions for viral pandemics. It is also galvanising funding of academic teams and small biotech companies working on taking new antibiotics from discovery through pre-clinical testing and into early trials in human volunteers.

In 2021, we are likely to see increased research focus on bacterial and viral diseases, which could give us a head start in future against potentially lethal pandemics.

More to come

From the development of thermo-stable vaccines to efficient vaccine delivery mechanisms and advances in surveillance mechanisms to effective models for immunising entire populations, health science is poised to scale greater heights in 2021. To make this quantum leap, the world will need to embrace change and adopt disruptive new ways of thinking.

I see 2021 as a year when we will witness huge medical and scientific advancements across the world, enabling us to come out of the crisis stronger than when we went into it. I also believe that a combination of testing, vaccination and surveillance will allow us to return to near normalcy next year.

“Everything that is done in the world is done by hope.” – Martin Luther King, Jr.