The government said on Tuesday it has approved recommendations for emergency use of Covid-19 vaccines that have already been cleared by regulators in the US, Europe, Japan and the UK, or that are mentioned in the World Health Organization (WHO)’s emergency listing.
The decision, which came after “comprehensive deliberation” by an expert committee, is aimed at “augmenting” the basket of vaccines available in India for fighting the pandemic “as well as accelerate the pace & coverage of domestic vaccination programme”.
WHAT DOES THIS MEAN?
A lot. In fact, it’s a bold and huge step, opening the doors for the smooth and quick entry of more and more vaccines that are already in use abroad. This could be a game-changer in India, which is the second-most affected country worldwide and is seeing a worrying spike in fresh cases linked to the viral and deadly infection.
SO WHAT CHANGES?
A fundamental tenet of the vaccine approval process in India during the pandemic. With the onset of Covid-19, the full and traditional cycle of vaccine development has seen significant changes with work progressing at a breakneck pace worldwide. The rigorous and time-consuming clinical trials have already been fast-tracked. Tuesday’s move gives an added impetus — that too a huge one — to a process already in top gear. It will ensure India gets more candidates, in addition to the three it has already approved for emergency use.
HOW IS THAT GOING TO HAPPEN?
For vaccines developed in foreign countries — Oxford-AstraZeneca’s Covishield (locally produced by Serum Institute of India) and Gamaleya’s Sputnik V (Dr Reddy’s is its India partner) — authorities have so far asked for extensive data before approving them. An example will explain this.
Hours after the UK approved the Oxford-AstraZeneca vaccine on December 30, an expert committee met to consider the applications by Serum Institute and Bharat Biotech (for the homemade Covaxin). Both were rejected, before being okayed within a week. While Serum was asked for more data on Covishield’s global trials, Bharat Biotech was told to give Phase 3 clinical trial information.
There is then another important concept: that of bridging trials. The idea is to build a “bridge” between a new region where a vaccine/medicine is introduced and the foreign place where it is already in use, and to ensure the medicine/vaccine’s safety and efficacy among the population in the new region.
To be sure, both Covishield and Sputnik V underwent bridging trials in India before they were approved for emergency use.
Now, according to the government, foreign vaccines fast-tracked for use will undergo “post-approval parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions”. In short, the government will not wait for bridging trials to begin inoculations. Officials said such studies can be conducted after the vaccines are available in India, though their outcome will be made public.
WILL THIS COMPROMISE SAFETY?
The Covid-19 vaccines that the government is expected to clear “have been granted emergency approval for restricted use by USFDA (US Food and Drug Administration), EMA (European Medicines Agency), UK MHRA (Medicines and Healthcare Products Regulatory Agency), PMDA (Pharmaceuticals and Medical Devices Agency) Japan”, or that are named in the WHO emergency use listing.
After the green light, “the first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunization programme within the country”, according to the government.
SO WHAT ARE THE VACCINES WE ARE LOOKING AT?
There are three vaccines in the WHO list —those by Oxford-AstraZeneca, Pfizer-BioNTech and Johnson & Johnson (J&J). The US FDA, too, has okayed three — those by J&J, Pfizer-BioNTech and Moderna. EMA has given four approvals — the three approved by the US and the one by Oxford-AstraZeneca. The UK has approved three — those by Pfizer-BioNTech, Moderna and Oxford-AstraZeneca. Japan has approved the one by Pfizer-BioNTech, while Oxford-AstraZeneca and Moderna have applied. So, India is looking at three new vaccines (those by Pfizer-BioNTech, Moderna and J&J).
WHAT IS AN EMERGENCY USE AUTHORISATION (EUA)?
It is a mechanism to facilitate the availability and use of medical measures, including vaccines, during public health emergencies, such as the Covid-19 pandemic, the USFDA says. “Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.”
WHAT’S THE CONVENTIONAL VACCINE DEVELOPMENT PROCESS?
Let’s discuss that too. In case of a pandemic or other emergencies, the development process is expedited. Work happened at an unprecedented pace during Covid-19. According to the USFDA, there is no predetermined timeline for vaccine development. “Typically, the better the scientific understanding of a pathogen and the disease it causes, the more efficient vaccine development.”
Typically, here’s how any vaccine development process goes:
• Making of the vaccine candidate (there are different types — those using adenoviruses, or common flu viruses, and the new mRNA vaccines etc.)
• Then they are studied in-vitro (in test tubes, before administering them on living organisms); sometimes this testing occurs in animals.
• The initial phases are termed the research and discovery stage, when scientists develop a rationale for a vaccine based on how the infectious organism causes disease, according to the USFDA. “Once a scientific finding is thought to have practical applications, in that it may be feasible to develop a vaccine candidate based on that finding, the research moves forward.”
• Preclinical studies in first small animals such as mice and guinea pigs, and then on large animals to “obtain information about how the vaccine works and whether it’s likely to be safe and work well in humans”.
• Then there are the Phases 1, 2 and 3 of clinical trials on humans.
• Phase 1: Emphasis during this phase is on safety and generally includes 20–100 volunteers who haven’t been exposed to the disease, according to the USFDA. “These studies are used to determine whether there are adverse reactions with increasing doses and, if possible, to gain early information about how well the vaccine works to induce an immune response in people.”
• Phase 2: It includes more people, where various dosages are tested on hundreds of people with “typically varying health statuses and from different demographic groups, in randomized-controlled studies”.
• Phase 3: According to the USFDA, the vaccine is now generally administered to thousands of people and the study generates critical information on effectiveness and additional important safety data.
• Based on data, efficacy and safety records, regulators, who also assess manufacturing capabilities, grant the final approval to a vaccine.