COVID-19 vaccines in less than a year – A new benchmark for human progress

Margaret Keenan, 90, from the UK, made history in more than one way when she became the first person in the world to receive a clinically approved vaccine against COVID-19. Pfizer-BioNtech’s vaccine was administered on December 8, 2020 at University Hospital in Coventry, a town 94 miles north-west of London. This was historic because, for the first time, a new vaccine had been developed and administered a total of 334 days after the first death from COVID-19 was reported in Wuhan, China. It is not only the fastest vaccine ever developed in human history, but also the world’s first messenger ribonucleic acid (mRNA) vaccine. It set another record for the fastest approvals after due process.

Creating a vaccine in less than a year is a new benchmark for human progress and scientific progress. Before COVID-19, the mumps vaccine, developed over four years and approved in 1967, held the record for the fastest vaccine to be developed. As COVID-19 wreaked havoc by disrupting economies and destroying livelihoods, scientists, governments and pharmaceutical companies have fought against time to find cures and develop vaccines. Governments, international nonprofits, multilateral agencies and private investors have committed billions of dollars in funding. Desperate need, public pressure and political will has allowed regulators to work with vaccine developers to give swift approvals.

As of 2021, nine COVID-19 vaccines using different technologies had received emergency use authorization, all in less than a year since the outbreak was reported. The vaccines come from Pfizer-BioNtech, Oxford-AstraZeneca from the UK, Bharat Biotech from India, Moderna from the US, Sputnik V and EpivacCorona from Russia and three vaccines from China. Two hundred and fifty other vaccines are in various stages of development.

Vaccine development has been accelerated by a synergistic combination of previous research with coronaviruses, advanced technologies and massive investments. Manufacturing for clearance and lightning-fast regulatory approvals helped reduce lead times. Years of basic ribonucleic acid (RNA) vaccine research have matured just in time to make the first mRNA vaccines possible now. The information from the study of the coronaviruses responsible for SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome) proved invaluable in the development of the vaccine.

Cryoelectron microscopy

The viral sequence for SARS-CoV-2 was deciphered in January 2020, just 10 days after the first cases of pneumonia were reported in Wuhan, China. Advances in cryoelectron microscopy have made it possible to visualize viral proteins in more detail and have made this quantum leap possible. Moderna could produce an experimental vaccine candidate in just 42 days due to breakthroughs in genomic sequencing that have helped define antigenic targets. The mRNA technology made it possible to rapidly print the RNA vaccine.

Once produced, testing for the safety and efficacy of vaccines takes time, requires huge sums of money and a large number of volunteers. Animal testing is followed by three phases of human clinical trials. The billions of dollars invested in their development have enabled COVID-19 vaccines to simultaneously conduct large trials at multiple sites. These “ decentralized clinical trials ” have innovatively deployed digital technologies and artificial intelligence for trial design, patient recruitment and evidence generation, dramatically reducing the time and cost of clinical trials.

The availability of large numbers of volunteers for vaccine trials across countries, age, gender, race, and ethnic groups has helped assess efficacy and safety in various demographic groups. Phase three clinical trials of the Pfizer-BioNTech COVID-19 vaccine included more than 43,000 participants and were spread across 150 sites. The Oxford-Astra Zeneca vaccine had over 24,000 volunteers and Moderna recruited 30,000 participants for their trials.

For the first time in history, vaccine manufacturing began even before clinical trials were complete and regulatory approvals could be obtained. Serum Institute of India, the world’s largest vaccine manufacturer, had produced 50 million doses of the Oxford-AstraZeneca COVID-19 vaccine by the end of December 2020. Pfizer and BioNTech used their manufacturing network to make available 50 million vaccine doses by the end of 2020.

With keen interest in presidents and prime ministers, regulators have set new records for swift approvals. Regulators have sought to balance the emerging need for a vaccine with adherence to procedures to ensure safety and efficacy. The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom approved the Pfizer BioNtech vaccine within days. The US Food and Drug Administration cleared the Pfizer and Moderna vaccines within weeks. Canada followed soon after. India’s Drugs Controller has issued new regulations to speed up reviews and speed up approvals for vaccines already approved in other countries. Rapid authorizations for clinical trials and approval of manufacturing licenses within seven days have been announced.

As the jubilation about the new vaccines spreads, one would do well to realize that it may be too early to celebrate. The vaccines are safe, effective and available, but their effectiveness against new emerging strains is still uncertain. It will be a long time before we overcome the daunting challenges of funding deployment, manufacturing the required doses, and delivering it to millions of people. Until then, universal masking, physical distance of two meters, early detection and timely care will continue to be the magic bullets that guide us. Vaccines are not the end of this journey, but certainly represent a giant step in the right direction.

(The author is an IAS official and a member of the Government of Tamil Nadu’s “Epidemic Surveillance, Interventions and Standardization of Health Care Protocols Team”, opinions are personal.)