What were the choke points in the manufacturing process that vaccine makers in India had to overcome to scale up COVID-19 vaccine supplies?
India launched the largest vaccination drive at the start of 2021, with COVID at its peak. It was always going to be a difficult task, no matter how well-planned the campaign would have been. The logistics of dispensing vaccine to such a large population, at the earliest, keeping in mind the training of staff, with precautions at hand, was a herculean
challenge. The choke points were at various levels.
Supply of required raw materials was a major challenge for vaccine manufacturing operations. The expected turn-around time was much lower than the production schedule. As a social responsibility, we had preferentially prioritised supplies to COVID vaccine manufacturers.
Rising to the occasion, the regulators also expedited the pathway of Emergency Use Authorisation (EUA), communicating with a large population and prioritising vulnerable and high-risk segments of the population, supply and safe preservation of vaccine, availability and accessibility of vaccines, and then, faced by a sudden shortfall. Now in hindsight, it may all seem objective on paper, but at that time, these were edging on emergency levels.
Every country had its own set of unique challenges pertaining to the vaccination drives. Roll-out challenges such as timely development of national vaccination plans, getting timely approvals on the vaccines, storing and availability of vaccines, training of staff, research efficacy and orientation of the masses to accept vaccines were some of the primary choke points that India, along with many other nations, had to overcome.
What were the measures taken to make the COVID-19 vaccines affordable without compromising on quality and safety?
The vaccine manufacturers are well aware and best placed of the protocols to follow for the efficacy of COVID-19 vaccines. Further, the regulators have checks and balances in place to ensure quality and safety. At Merck, we collaborate with vaccine manufacturers to provide them with technologies and technical and regulatory consulting to maximise quality and safety.
What was the role of Merck’s CollaborationLabs in India and APAC to make this happen?
The biggest scientific breakthrough in the 21st century would probably have to be the development of the COVID vaccine. And yet, there were challenges because of the changing nature of the variants that posed serious and unknown threats to the lives of people. The mutant variants and their high infectivity were throwing everyone off-guard.
Merck’s Collaboration Labs in India and APAC rose to the challenge and stepped up their capabilities to support vaccine manufacturers in various ways. Some of the ways that the organisation helped were by technical consultation for process developments, regulatory services for risk mitigation, patient safety and approvals, expanding our facilities and supplying in the midst of severe global disruption to facilitate the early launch of vaccines for immunisation.
We prioritised supplies to help vaccine manufacturers at any given point in time to provide timely aid to the populace. We are also strengthening our capacity for developing and manufacturing vaccines and treatments based on messenger ribonucleic acid (mRNA) technology acquisitions.
What are the key technologies that lifescience companies will have to invest in to deliver the next round of vaccines, therapeutics and test kits as COVID-19 variants continue to threaten populations?
For COVID vaccines, under development protein sub unit, viral vector and nucleic acid-based vaccines are the top modalities being explored by companies, and molecules are at different stages of development.
Our endeavour at Merck has been to expedite the journey of the vaccine molecule with our technologies and expertise.
What are the technologies required to research and refine intra-nasal spray vaccines, mRNA vaccines and other such delivery platforms?
Over the past two years, Merck’s Life Science business sector has made significant investments to advance traditional and novel modalities – Monoclonal Antibody (mAb), Antibody-Drug Conjugates (ADC), high-potency API (HP-API), viral vector and Messenger Ribonucleic acid (mRNA) through acquisitions, expansions andlaunch of new product platforms/technologies.
Our recent acquisitions have enabled us to become one of the leading CMO players in mRNA vaccines and gene therapy, offering an integrated CDMO across the value chain pre-clinical to commercial. In addition, we have also launched new product platforms for gene therapy and have specialised teams, enabling our customers to bring new curative treatments to market.
Our goal is to invest in using path-breaking technologies to simplify treatment and make it accessible to all those in need, in collaboration with drug manufacturers across the world, and scale up to make treatments and therapies available to all.
How is Merck preparing for other disease threats like monkeypox virus, etc?
Many vaccine manufacturers have been working on developing vaccines for monkeypox. Our endeavour at Merck has been to expedite the journey of the vaccine molecule with our technologies and expertise. Our capacity expansions will strengthen our global manufacturing footprint, allowing us to meet unprecedented demand and help get life-saving vaccines and therapies to more patients, faster.