As the new Coronavirus overwhelms the world, since its global outbreak, up until November 29, 2020, over 1,458,305 people have died from this pandemic. Understandably, the Governments in all countries are frantically searching for some robust remedial measures to prevent these unfortunate deaths, besides protecting livelihoods of a vast majority of people.
For this purpose, experts considered effective preventive measures, such as vaccines could help taming this menace, alongside existing personal prevention measures. Accordingly, scientists around the world, have are hard to accelerate development and manufacturing of safe and effective Covod-19 vaccines, within the prescribed guidelines. Equally important is the fact these vaccines must be safe with predictable effectiveness- for all age groups.
The good news is, vaccines are now a distinct possibility in the near future, with the positive interim Phase III clinical trial reports pouring in. It gets reflected in the remark of the Director General of the World Health Organization (WHO), on November 23, 2020, at the media briefing on Covid-19. He said: There is now real hope that vaccines – in combination with other tried and tested public health measures – will help to end the pandemic.
Interestingly, amid these reports, a lurking fear of many experts also surfaces – on the impact of possible side effects, that Covid vaccine may cause, besides their medium to long term efficacy in human subjects. But, with the mounting number of deaths, near collapse of the global economy, including India, there isn’t any more time to watch and wait.
Apparently, all governments now want some scientifically relevant vaccines, instead of nothing. This article will deliberate on the one hand – an unprecedented achievement, alongside some critical concerns – voiced even by the Indian Prime Minister. Let me begin with the apprehensions, as expressed by some domain experts on some rough edges, as it were, in the process of its development.
Queries on vaccine dosing, efficacy, safety and testing:
On November 23, 2020, AstraZeneca and Oxford reported interim results of their vaccine with the average efficacy of 70% prevention. This sounded good to many, as it falls within the expectations of above a 50% standard that the FDA had set for Covid vaccines. However, the puzzling part in this result was – bigger (standard) doses of the vaccines were less efficacious. The vaccine was only 62% effective in a group that got two full doses spaced about a month apart. But among about 2,700 people who got a half-dose followed by a full, the number rose to 90%, the report highlighted. This incident prompted several questions about the most effective dose of AstraZeneca and Oxford vaccine, including its safety record and the approach to testing. Consequently, apprehensions surfaced whether the Drug regulators will clear it, based on the currently available data.
It now appears, AstraZeneca ‘s Covid-19 vaccine is ‘headed for an additional global trial as the drug maker tries to clear up the uncertainty and confusion surrounding favorable results in its current study.’ Incidentally, in India - AstraZeneca and Oxford vaccine will be manufactured by Pune-based Serum Institute of India (SII) under a collaborative arrangement. Let me now dwell on a broader as aspect in this space.
Could current Covid vaccines become useless in the future?
There isn’t an iota of doubt that developing Covid vaccine in ten months, which otherwise takes around ten years – is an unprecedented achievement. However, there are several other important areas in this space, where pundits have expressed uneasiness through various articles.
One such paper is titled, ‘Don’t rush to deploy COVID-19 vaccines and drugs without sufficient safety guarantees,’ published in the Nature on March 16, 2020. According to the author, a critical point in this regard is to consider ‘the potential for emerging and re-emerging Coronaviruses to cause future outbreaks.’
This is because, ‘the virus behind COVID-19 might mutate in ways that would make previously effective vaccines and antivirals useless.’ Testing vaccines and medicines without taking the time to fully understand safety risks, could bring unwarranted setbacks during the current pandemic, and into the future. ‘Despite the genuine need for urgency, the old saying holds – ‘measure twice, cut once’, the author commented.
The article concluded by suggesting, ‘any regulatory agency considering ways to accelerate treatments into testing should also weigh up how likely these drugs are to work beyond this particular Coronavirus.’ Moreover, according to the WHO, it’s too early to know if COVID-19 vaccines will provide long-term protection.
Possible side-effects of COVID-19 vaccines:
As people’s hopes swell, expecting Covid vaccines to ultimately end the deadly global pandemic, experts caution about their reported – annoying and unpleasant side effects. The November 12, 2020 paper – ‘Time to Discuss Potentially Unpleasant Side Effects of COVID Shots? Scientists Say Yes,’ published by the Kaiser Health News (KHN), also articulated similar apprehension.
It said, most Covid vaccines, including much publicized ones from Pfizer and Moderna, will require two doses to work, injections that must be given weeks apart, as company protocols show. Scientists anticipate the shots will cause enervating flu-like side effects — including sore arms, muscle aches and fever — that could last days and temporarily sideline some people from work or school.
Even with the Pfizer vaccine, which is touted to be over 90% effective, 1 in 10 recipients would still be vulnerable. There could also be a possibility that a vaccine may not suit everyone due to side-effects, especially the most vulnerable elderly population. That means, at least in the short term, as population-level immunity grows, people can’t stop social distancing and throw away their masks, the report emphasized. Even Prime Minister Modi has informed the nation about possible side effects of Covid vaccines.
PM Modi also warns of possible vaccine side-effects:
Being adequately briefed on the above perspectives related to Covid vaccines, the PM has also warned the nation about the possible side-effects. This is probably to ensure that the unpleasant experience of side-effects, after being administered the first dose, do not catch the population off-guard. Mostly because, no one should miss the second dose of vaccine for the same.
He said, during a recent video conference with the state chief ministers, ‘like many other popular medicines, any COVID-19 vaccine could lead to side-effects in some people.’ Emphasizing that both speed and safety are equally important in launching a vaccine, he assured that ‘the government would only go by science in finalizing a vaccine for the country.’
Is something better than nothing?
In the current situation, it appears so, as there is no other alternatives, except maintenance of social distancing, frequent hand sanitizing and wearing masks while outdoors. The Prime Minister also articulated sans any ambiguity: ‘Whatever vaccine makes it through the world’s certified processes, we will have to accept them and move ahead.’
In the meantime, he urged the states to keep distribution infrastructure, such as cold storages ready, the report said. Interestingly, according to Serum Institute CEO Adar Poonawalla, India could approve the emergency use of the Oxford-AstraZeneca COVID-19 vaccine by December 2020.
That said, for mass vaccination of the population across India, another factor that is extremely important to decide which vaccine to go for – is the required storage temperature of various Covid Vaccines under development.
Required cold chain storage temperature of various Covid vaccines:
Required cold chain storage temperatures of various Covid vaccines are as follows:
|Oxford-AstraZeneca||Viral Vector (genetically modified virus)||Two||62-90%**||Regular fridge temp.|
|Moderna||RNA (part of virus genetic code)||Two||95%||-20C up to six months|
|Gamaleya (Sputnik V)||Viral Vector||Two||92%||Regular fridge temp.|
Source: Respective Companies, WHO – BBC News. *Preliminary Phase III results. **Two full doses: 62%, A half dose followed by a full dose: 90%, Average: 70%
From the above table, it appears, from the perspective of continuous cold chain storage facility of vaccines – till these are administered to each person, Oxford-AstraZeneca and Russian Sputnik vaccines will be more practical, despite issues with them. Viewing from this perspective, as well, it appears ‘something is better than nothing’ term can be applied in this area, as well.
The Covid pandemic continues to worry India, immensely. As on November 29, 2020 morning, India recorded a staggering figure of 9,393,039 of Coronavirus cases with 136,733 deaths. The threat of subsequent waves for further spread of Covid infection now looms large in many states.
Unprecedented speed in developing vaccines to effectively combat Covid Pandemic has created some initial issues. Some of these Covid vaccine challenges include, vaccine side effects, its future usefulness, or challenges towards maintaining required stringent cold chain storage requirements, especially in a country like India. Powder version of Covid vaccines, in the future, would possibly resolve this issue for all countries, across the world.
Currently, in tandem with keeping the cold-chain distribution infrastructure ready, at least, for vaccines that require regular fridge temperature, there is a need to make people aware of Covid vaccine side-effects. Otherwise, after getting first shot of a Coronavirus vaccine, many people may get so scared of its side effects that they may not come back for the second dose. If this happens, the very purpose of mass vaccination will get defeated.
However, from the Indian perspective, Covid vaccines that the country, hopefully, will shortly get, may not be the best, out of the available ones, in terms of safety and efficacy. But, for combating Covid Pandemic across India at this juncture, I reckon, the good old dictum still holds good – ‘something is better than nothing.’
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.