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

90-year-old Margaret Keenan becomes the first patient in United Kingdom to receive the Pfizer-BioNTech COVID-19 vaccine, in Coventry on December 8, 2020.   | Photo Credit: AP

Ninety-year-old Margaret Keenan from the United Kingdom created history in more ways than one when she became the first person in the world to receive a clinically approved vaccine for COVID-19. The vaccine from Pfizer-BioNtech was administered on December 8, 2020 at the University Hospital, in Coventry, a city, 94 miles to the northwest of London. It was historical because, for the first time, a new vaccine had been developed and delivered in all of 334 days after the first COVID-19 death was reported from Wuhan in China. This is not only the fastest vaccine ever developed in the history of mankind but also the world’s first messenger Ribonucleic Acid (mRNA) Vaccine. It set another record for the speediest approvals following due process.

Creating a vaccine in less than a year is a new benchmark for human progress and scientific advancement. Before COVID-19, the mumps vaccine, developed over four years and approved in 1967, held the record for being the fastest vaccine to be developed. As COVID-19 wreaked havoc by disrupting economies and wrecking livelihoods scientists, governments and pharmaceutical companies raced against time to find treatments and develop vaccines. Governments, international non-profits, multilateral agencies, and private investors committed billions of dollars in funding. Desperate need, public pressure and political will ensured that regulators worked with vaccine developers to give speedy approvals.

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

Vaccine development was fast-tracked by a synergistic combination of past research with Coronaviruses, cutting-edge technologies, and massive investments. Manufacturing in anticipation of authorisation and super quick regulatory approvals contributed to crashing timelines. Years of basic research on Ribonucleic Acid (RNA) vaccines matured just in time to make the first mRNA vaccines possible now. Insights from the study of Coronaviruses causing SARS (Severe Acute Respiratory Syndrome) and MERS (Middle East Respiratory Syndrome) proved invaluable in developing the vaccine.

Cryo-electron microscopy

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

Once produced, testing the vaccines for safety and efficacy is time-consuming, requires huge amounts of money and large numbers of volunteers. Animal tests are followed by three phases of human clinical trials. The billions of dollars poured into their development made it possible for COVID-19 vaccines to conduct large trials at multiple sites simultaneously. These ‘decentralised clinical trials’, 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 a large number of volunteers for vaccine trials across countries, age, gender, race, and ethnic groups helped assess efficacy and safety across diverse demographics. The phase three clinical trials of the Pfizer-BioNTech COVID-19 vaccine included more than 43,000 participants and was spread over 150 sites. The Oxford–Astra Zeneca vaccine had more than 24,000 volunteers and Moderna recruited 30,000 participants for their trials.

For the first time in history, vaccine manufacturing started even before clinical trials were completed and regulatory approvals could be received. Serum Institute of India, the largest vaccine manufacturer of the world, 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.

Speedy approvals

With Presidents and Prime Ministers taking keen interest, regulators set new records for speedy approvals. Regulators sought to balance the emergent need for a vaccine with procedural compliances to ensure safety and efficacy. The Medicines and Healthcare Products Regulatory Agency (MHRA) of the U.K. approved the Pfizer BioNtech vaccine within days. The U.S. Food and Drug Administration cleared both the Pfizer and Moderna vaccines within weeks. Canada followed soon after. The Drug Controller of India issued new regulations for expediting reviews and accelerating approvals for vaccines already approved in other countries. Speedy permissions for clinical trials and approval of manufacturing licences within seven days were announced.

As jubilation about the new vaccines spreads, one would do well to realise that it might be too early to celebrate. The vaccines are safe, effective, and available, but their efficacy against newly emerging strains still remains uncertain. It will be quite a while before we surmount the daunting challenges of funding the rollout, manufacturing the required doses and administering it to millions of people. Till then universal masking, two metres physical distance, early detection and timely care will continue to be the magic bullets that will see us through. Vaccines are not the end of the road in this journey but are certainly a giant leap in the right direction.

(The author is an IAS officer and member of the “Team for epidemic monitoring, interventions and standardisation of health care protocols” of the Govt. Of Tamil Nadu, Views are personal.)

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Printable version | Mar 9, 2021 6:20:27 AM |

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