As the year of the pandemic is approaching its end, people across the globe are eagerly waiting for a COVID 19 vaccine. The novel coronavirus has halted the world as millions who got infected by the virus reel from the symptoms while others confine themselves to their homes to avoid the infectious disease. Due to the crippling effects of the pandemic, scientists are racing to develop a safe vaccine by next year when vaccines typically take years of research and testing. According to the NY Times, researchers are currently testing 55 vaccines in human clinical trials and 87 vaccines are in preclinical stages but are being tested on animals.
The preliminary work on a potential vaccine began in January when scientists were attempting to understand the SARS- Cov-2 genome. The first vaccine trial for safety in humans started in March and 13 vaccines have reached the final stages of testing. It's important to have a number of vaccine options as some might fail while only a few may succeed in producing antibodies against the virus. Before learning about the top contenders in the vaccine race, let us take a quick look at the stages an experimental vaccine goes through before being distributed.
Stages of vaccine testing
1. Preclinical testing: First, a new vaccine is tested on cells and animals such as mice or monkeys to check if it produces an immune response. For lack of knowledge on the safety of the vaccine, it's not tested on humans.
2. Phase 1 (Safety trials): To test the safety and dosage of the vaccine, scientists administer the vaccine to a small group of people. This also helps confirm if the vaccine stimulates the immune system.
3. Phase 2 (Expanded trials): At this stage, scientists give the vaccine to hundreds of people split into age groups such as children, young adults and elderly to see if the vaccine affects them differently. They also test if the vaccine is safe for all age groups.
4. Phase 3 (Efficacy trials): Now scientists administer the vaccine to thousands of people and observe how many become infected, compared to the group who was injected with a placebo. This tests if the vaccine can protect people from coronavirus. In June, the Food and Drug Administration advised vaccine developers that the potential vaccine should protect at least half the people who receive it. Since these trials are larger, they also reveal evidence of rare side effects that might have not appeared in earlier studies.
5. Early or Limited approval: This is a controversial action as experts say rushing the approval of a vaccine can hinder the hunt for more effective ones and a vaccine without phase 3 results can pose serious risks as the long-term effects of the new vaccines are still unknown.
6. Approval: National regulators in each country review the results of the trial and decide whether to approve the vaccine or not. Many countries such as China and Russia have attempted to provide an emergency use authorization to vaccine developers due to the urgency of the situation. But usually, it needs formal approval and after it is licensed, researchers often continue to study people who receive it to make sure it's safe for long-term use.
7. Combined Phases: This is a way to accelerate the process of vaccine creation. For example, certain coronavirus vaccines are in Phase 1/2 (a combination of Phase 1 and Phase 2) meaning they are testing their first time on hundreds of people directly.
8. Paused: As stated earlier, not all vaccines will succeed. So, if researchers notice worrying side-effects in volunteers, they can put the trial on pause. After further investigation, the trial may resume or be rejected.
At the moment, there are four vaccines that have shown promising results in their large-scale human trials and are waiting for final approval.
The top four contenders in the race for the COVID vaccine
Pfizer and BioNtech's vaccine: This vaccine is headed by the American multinational pharmaceutical corporation, Pfizer and the German company BioNTech. On November 9, they came out with good news by presenting preliminary data indicating that their coronavirus vaccine was over 90% effective. They were the first vaccine developers to announce such promising results.
They chose the route of combined phases to speed up the vaccine development process. So, in May Pfizer and BioNTech launched a Phase 1/2 trial on two versions of an mRNA vaccine. Both versions led to the production of antibodies and immune cells against the virus but one of the versions had more intense side-effects such as fever and fatigue, making the alternate option with fewer side-effects the selected option.
After the May trials, they tested on thousands of volunteers in the US, Argentina, Brazil and Germany. In Oct, they even gained permission to start testing the vaccine on children as young as 12 initiating the first American trial on kids.
Pfizer's chief executive has assured that it could have 30 to 40 million doses of the vaccine before the end of the year, enough for 15 to 20 million people to get an initial shot and a booster three weeks later. The company also said it will most likely apply for emergency authorization in the third week of November. Then, the FDA will consult with a committee of experts for weeks to analyse the detailed data about the vaccine's safety, efficacy and ability to manufacture.
A major drawback of the Pfizer vaccine is its storage which is why transporting the vaccine from the factory into people's arms could be a challenge. Since Pfizer and BioNTech’s preparation is based on mRNA, which falls apart unless it’s kept in a deep freeze, it will need to be transported in temperature-controlled boxes. The vaccine has to be chilled to minus 70 degrees Celsius until it's ready to be injected.
Sputnik V: The vaccine being developed by Russia which is claimed to be 95% effective will be priced at a much lower cost (less than $10) than rival vaccines. Moscow is aiming to produce more than 1 billion doses for domestic and international use.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, told Reuters that new clinical trial data based on 18,794 patients who got two doses of the Sputnik V vaccine showed that it was 91.4% effective by day 28 and over 95% effective by day 42. Surprisingly, no adverse side-effects were reported during the trial.
Moderna: In January, Moderna, an American biotechnology company, started working on developing vaccines based on messenger RNA (mRNA) to produce viral proteins in our bodies. The vaccine contains genetic instructions to create a coronavirus protein called a spike. So, when it is injected into cells, the vaccine instructs them to make spike proteins which get released in the body and instigate a response from the immune system.
On November 16, Moderna announced that their preliminary analysis of the trial showed the vaccine to be 94.5% effective. Another hopeful result from Moderna vaccine's trial was that the vaccine seems to protect people from severe disease. Much like Pfizer, Moderna also plans to submit an application for emergency authorization in the coming weeks. The US has generously supported Moderna's efforts by providing them with nearly $1 billion in support.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, commented on Moderna and Pfizer's promising data saying the results were better than he had anticipated. The US has ordered 100 million doses of Moderna vaccines through the government's fast-track program from coronavirus vaccines- Operation Warp Speed.
Oxford and AstraZeneca’s vaccine: This is COVID 19 vaccine candidate is being developed by Oxford University in partnership with AstraZeneca, a British–Swedish multinational pharmaceutical. In a recent press release, Oxford University announced that their vaccine showed overall effectiveness of 70.4% - comparatively lower than the Moderna vaccine and Pfizer's vaccine.
However, these results can change. Also, the Oxford vaccine was administered to one group of people as two standard doses, which led to 62% effectiveness. But when it was given to another group of volunteers as a smaller dose followed by a standard second dose, the effectiveness reached 90%. It's not clear why this happened. Professor Andrew Pollard, one of the lead researchers on the project, described the results as “intriguing”. He also said that lower doses mean there would be more vaccine doses available.
The vaccine has so far reported having a good safety record with no deadly side-effects. Another great characteristic of the vaccine is its easy storage - it can be stored in a domestic fridge which is a huge advantage in poorer countries where low-temperature transportation is unaffordable. The Oxford Vaccine is also cheaper ($4) than Pfizer and Moderna's mRNA vaccine which is around $20 and $33, respectively as AstraZeneca has made a "no profit pledge".
What about India's COVID 19 vaccine - Covaxin?
India's coronavirus vaccine - Covaxin developed by Bharat Biotech, an Indian biotechnology company, said on Sunday that the vaccine will be at least 60% effective, according to clinical human trial data.
It can be a possible contender in the vaccine race as the World Health Organisation (WHO), United States Food and Drug Administration (USFDA) and India's Central Drugs Standard Control Organisation approve a respiratory disease vaccine if it is at least 50% effective. In a press release, the firm said that it is now trying to reach a higher efficacy rate and that they are positive about it being above 50%. “Chances of the vaccine being less than 50% effective are remote, as suggested by our trial results so far,".
The biotech company said that they plan to roll-out the vaccine by mid-2021 after approval. "If we get all the approvals after establishing strong experimental evidence and data, and efficacy and safety data in our last stage of trials, we aim to launch the vaccine in Quarter 2 of 2021,” the firm told News18.
Bharat Biotech researchers started the Phase 3 trial of Covaxin earlier this month. The trials involve 26,000 volunteers across India and are being conducted in partnership with the Indian Council of Medical Research. It's the biggest clinical trial in process for a vaccine candidate in India.
However, the announcements received criticism as well by the All India Drug Action Network (AIDAN). Malini Aisola, the co-convenor of the network, said in a tweet, "@BharatBiotech says vaccine will be at least 60% effective before any results are known. Has not shared Phase 1 and 2 results. Doesn’t come clean on adverse events. Detailed protocols for Phases 1/2 and Phase 3 are not in the public domain(sic)."
Dr VK Paul, a member of the Centre's expert group on vaccines, responded to such allegations saying the data from trials will be available to the public but only after completion of Phase 3 trials as reported by News18. He dismissed any allegations of data intentionally being kept from the masses.
Who will get the vaccine first?
The vaccine may arrive next year but it is unlikely that young adults will receive it on arrival. Rather, the vaccine will be distributed based on who requires it the most during the COVID 19 pandemic. The Union Health Minister Dr Harsh Vardhan told India that health and frontline workers will be given priority when coronavirus vaccine arrives. “A list of the data of health workers is being prepared and will be upload soon”, he added further.
The list has categorized people in four groups in order of preference on who will be administered the vaccine first.
- Healthcare professionals: More than 1 crore medical workers including MBBS students, doctors, nurses, Accredited Social Health Activists will be the first ones to receive the first shot of the vaccine.
- Frontline workers: Considering the tremendous risk taken by frontline workers to continue essential services and offices - they will be the second ones to receive the vaccine. So, this includes municipal corporation staffers, police officers and even armed forces personnel.
- Senior citizens: This includes people over the age of 50. Since they fall within an age group with high risk for the contracting the virus, they have been identified as priority groups who would be provided vaccine doses in the initial phase.
- Special category people: This refers to people below the age of 50 who suffer from co-morbidities or require special medical care.
The Health Minister also reiterated that around 25-30 crore Indians will be inoculated with the coronavirus vaccine by September 2021.
Has India ordered a vaccine?
According to the Economic Times, India has pre-ordered 600 million doses of the potential COVID 19 vaccine and by leveraging its manufacturing capacity is negotiating for another billion doses. It's being estimated that the total number of vaccine doses (if approved) should be plenty to vaccinate half of the country's 1.3 billion population given the fact that most of the vaccines have to be administered in two doses.
Serum Institute of India Ltd, the world’s largest vaccine maker, is preparing for the production of AstraZeneca's vaccine aiming to have 100 million doses ready by December. The company is hoping to carry out an inoculation drive if the final-stage trial data proves AstraZeneca's vaccine to be effective in creating an immune response against the virus. The firm may get emergency authorization from New Delhi by December, said Adar Poonawalla, chief executive officer of the family-owned company based in Pune. The initial amount of vaccines will go to India, Poonawalla confirmed in an interview on Thursday.
In the same interview, Poonawalla stated that it will take until 2024 to vaccinate the entire world and two subsequent years to see a real reduction in infections due to affordability and manufacturing problems.
In India, he foresees a challenge in getting the vaccine to India's 1.3 billion population, especially to people living in remote rural areas where adequate healthcare is absent. Moreover, looking at Moderna and Pfizer, it might be difficult to distribute the two in India due to logistical problems and the high cost of the vaccines. But to ensure low and middle-income countries get an equitable allocation of vaccines, COVAX, an initiative that was launched in April by the WHO, Gavi Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI), is trying to brainstorm solutions for all countries to have access to the vaccine.