- At least six COVID-19 vaccines have been rolled out in less than a year. Vaccine approval process usually takes over a decade
- Companies halted other ongoing projects, advance contracts were signed, governments poured in billions of dollars to speed up COVID-19 research
- In India, SII, Zydus Cadila, Dr Reddy's and Bharat Biotech -- all got the DCGI nod to combine clinical trials
- The US-based Pfizer and Moderna worked on next-gen mRNA technique. It's expensive but faster, and comes with fewer side-effects
- All vaccines that have been approved took "emergency approval" route. They presented interim clinical data of few participants for regulatory approval
The pace at which pharma companies developed coronavirus vaccines is unprecedented as most vaccines take up t0 10 years to be ready for mass use. Yet, at least six COVID-19 vaccines have been rolled out in less than a year -- the best record in history. No other vaccine for any diseases had been deployed so rapidly.
It took 20 years to develop a vaccine against chickenpox and 40 years before it received necessary regulatory approval. The vaccine against shingles or herpes zoster took 53 years before it was finally licensed. The vaccine against Hepatitis B was developed in 12 years. The vaccine against measles took nearly 60 years of science and millions of vaccinations to prove its efficacy.
So how did scientists create COVID-19 vaccine in less than a year?
Funding worth billions of dollars
For a change, it was lucrative to produce the vaccine. There was immense pressure on governments to develop a vaccine at the earliest due to the destruction COVID-19 pandemic was unleashing. This led to a race among pharma companies to be the first to develop a vaccine. Companies halted their other ongoing projects to fully divert resources to COVID-19 vaccine development.
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Governments poured in billions of dollars to speed up COVID-19 research. Advance contracts were signed with companies for billions of vaccine doses. The World Bank approved $12 billion for developing countries to produce vaccines and ensure equal distributions. The US federal government made a $1.95 billion deal with Pfizer to develop a COVID-19 vaccine and delivery of 100 million doses. Although Pfizer didn't take the funding, the government's promise provided it a necessary safety net to work with full force.
Similarly, Moderna received $955 million public money for COVID-19 vaccine poduction. Vaccine developer Novavax was awarded $1.6 billion to become part of the Operation Warp Speed. AstraZeneca, Johnson & Johnson, Novavax, and Sanofi-GSK -- all received US government funding that helped them prioritise the vaccine. Many countries, including India (Rs 900 crore), pumped in millions to speed up vaccine research. COVAX, led by organisations like Gavi and the World Health Organisation, was also formed to accelerate development and manufacture of COVID-19 vaccines.
Before COVID-19 struck the world, vaccines were developed one step at a time. The WHO data says pre-clinical trials alone took around 1-2 years. Phase 1 and Phase 2 clinical trials were conducted in a span of three years and Phase 3 generally took another three years. Add to that the time that's taken in scaling up infrastructure, manufacturing, approval, and distribution. All this took around 4-5 years. Most vaccines received approval after about 10 years.
However, all these steps were completed in less than a year, allowing speedy clinical trials and fast approval for the coronavirus vaccine. Regulators even permitted trials to be clubbed. For example, the Drug Controller General of India (DCGI) allowed Serum Institute to club phase 2 and 3 in August. Dr Reddy's was also allowed to conduct phase 2/3 of Russia's COVID-19 vaccine Sputnik V. Pharma majors Zydus Cadila and Bharat Biotech also got the DCGI nod to conduct phase 1/2 clinical trials in July.
Newer and safer techniques
New and emerging techniques also helped speed up vaccine development. Companies used different approaches to develop vaccines that could prepare the immune system to recognise and protect against coronavirus. Many are going the modern way of developing virus vectors (like Oxford-AstraZeneca's vaccine) -- in which a weakened virus delivers antigen in the body -- while others are using tried and tested methods like inactivated vaccines like Bharat Biotech's Covaxin.
Among all, there are also those that have chosen a less travelled path like the next-gen mRNA technique. Vaccines developed by Pfizer-BioNTech and Moderna are based on the new messenger RNA or mRNA technique, which is being used for the first time. The mRNA technique works differently. In mRNA, coronavirus or SARS Cov2 is covered with 'spike proteins', with which it grabs human cells.
When someone is given the vaccine, the mRNA genetic material present in it instructs the human cell to make the 'spike protein'. Seeing these spike proteins, our immune system develops antibodies without being exposed to the virus. This new technique is believed to be safer but more expensive than the traditional ones and there are little chances of spike proteins infecting a person from COVID-19. It's also faster to develop.
Emergency Use Authorisation
The companies presented interim trial data to deliver their vaccine in the market in record time. They took the "emergency approval" route for this purpose. But the pressure to produce vaccines in record time also led to implausible claims by companies.
Top vaccine makers Pfizer and Moderna claimed efficacy of over 90 and 94.1 per cent. A few days later, Pfizer revised its efficacy claims to 95 per cent. Moderna also revised its efficacy to 90 per cent. AstraZeneca made it worse by releasing multiple data points for the efficacy of its vaccine. Oxford-AstraZeneca's vaccine is the same vaccine that the Serum Institute is producing in India.
New vaccines are rarely certified above 90 per cent for efficacy. In fact, most vaccines get certified in the 40-60 per cent efficacy band. Even a 70 per cent efficacy is considered excellent in the world of vaccines. In most cases, trials were also clubbed to deliver vaccines in record time. The interim COVID-19 trial data was then presented to regulators, which also faced pressure from governments and public at large to grant speedy approval.
Dangers of speedy approvals
There are voices who believe that fast-tracked vaccines may carry a few risks. Elissa Prichep, Precision Medicine Lead, World Economic Forum, said that creating a vaccine expeditiously, without appropriate testing, could put healthy people at risk. "One area of risk is vaccine enhancement, meaning the disease is more harmful to a vaccinated person," Prichep said.
Also, chances of the vaccine not being effective are high. "Vaccine development is characterised by a high failure rate - often 93% between animal studies and registration of a product," Dr Jerome Kim, Director-General of the International Vaccine Institute, said at the World Economic Forum in June.