Image by David Mark from Pixabay

We are now in the middle of an unprecedented and biggest ever expansion of production and use of more and more vaccines ever seen in world  history, mainly related to COVID-19. The WHO reported on January 12 2021—As of December 2020 there are over 200 vaccine candidates for COVID-19 being developed. Of these at least 52 candidates are in human trials. On May 18 President Biden said the USA will be sending over 80 million COVID-19 vaccines abroad over next few weeks and will also emerge as the country for sending the most vaccines outside the country ( reported in The Statesman May 19 2021).

Writing in the context of only India The Tribune wrote in its number one news on May 14—The Central government has said on May 13 that it is expecting that over 200 crore ( one crore=10 million) doses ( of Covid vaccine) would become available in India between August and December this year, and reaching up to 300 crore doses by the first quarter of 2022. 

The Times of  India ( May 14 ) provided the break-up of the projected availability of over 200 crore doses in August–December this year, as provided by official sources -75 crore doses of Covishield, 55 crore doses of  Covaxin, 16 crore doses of Sputnik V (vaccine licensed in India) and stocks of yet to be licensed vaccines –Bio-E Vaccine (projected availability of 30 crore doses between August and December 2021 ), Zydus Cadila DNA Vaccine (5 crore doses ), Novavax (SII) 20 crore, nasal vaccine (BB) 10 crore, Gennova 6 crore. (Chandigarh editions of both newspapers quoted here).

The Bhaskar newspaper of the same day confirms  further in its main headline news of the same day that by the end of this year people will India will be able to choose between 8 Covid vaccines with a total stock of over 200 crore vaccine doses.

The Hindustan Times reported earlier on April 14 that corona virus vaccine cleared for use in western countries and Japan will get fast-track approval in India and also that Sputnik Vaccine of Russia  has also been approved and deals for making 850 million doses a year has been signed with various companies.

The budget of this is not mentioned by newspapers, nor is it mentioned whether the spending on these in a situation of overall reduced resources and income will involve curtailment of other essential spending , and if yes then which spending is likely to be cut. What is well-known is that India faces a severe resource crunch for essential needs relating to public health, school education, nutrition, sanitation and poverty alleviation schemes.  

However there are some even more important questions such as those relating to safety. As the race for developing and commercializing COVID-19 speeds up across the world, some saner voices including  those of senior scientists are voicing increasing concern over the safety aspect of  Covid vaccines which should be treated as the most important aspect of vaccine development. According to a  report on an international symposium organized by the Indian Council of Medical Research to discuss novel ideas in science and ethics of vaccines against COVID 19 , “most speakers highlighted the need for adopting best regulatory and ethical practices even at the cost of speed …”

One reason for safety concerns is that the normal time taken to develop a vaccine is about a decade (120 months).  The fastest vaccine ever developed earlier was for mumps and even this  vaccine took four years to develop. Now the various COVID-19 vaccines being mentioned are being developed within a period of 7 months to 17 months. Is this adequate time for all safety and efficacy aspects, as well as for studying the more specific possibilities of risks for special groups of people? This question should be answered in a completely honest and unbiased way before we go ahead on a fast track.

On August 11 2020 Russia launched a COVID-19 vaccine, described by President Vladimir Putin as the world’s first. It was also announced that industrial production of the vaccine will start in September and 20 countries have already ordered a billion doses. 

Image:Pixabay

However Russia’s Association of Clinical Trial Organizations responded with a warning, “ Fast-tracked approval will not make Russia the leader in the (vaccine), it will just expose consumers of the vaccine to unnecessary danger.” 

However Russia is by no means the only guilty party in jumping steps to win a dubious race; several western multinational companies  and other leading manufacturers also face criticism for not giving adequate importance to safety in the rush for speed. The same can  no doubt be said about the Operation Warp Speed  announced by President Trump earlier to speed up vaccine development and its extremely rapid commercial production in the USA.

Dr. N.K. Mehra, Indian Council of Medical Research emeritus scientist and former Dean of the All India Institute of Medical Sciences N.Delhi, wrote recently, “ The critical aspect of the process is to develop a protein that must be close to the original virus, and against which the body is able to raise antibodies for neutralizing the virus. Any deviation could lead to the development of “blocking factors’’ through a process called Antibody Dependent Enhancement (ADE).” 

This eminent scientist explains further, “Simply put, rather than neutralizing the virus, such antibodies could do the opposite, namely facilitate further virus entry into cells. This has happened earlier for the dengue virus where the vaccine, rather than conferring protection, actually acted like a silent primary infection.” (Covid 19: Decoding the global search for a vaccine, published in  The Hindustan Times).

Other more detailed  reports on the use of dengue vaccine in the Philippines state that a very large number of children who should  not have been given this vaccine were given this vaccine, leading to death of a large number of children, public protests , court cases and large-scale loss of faith even in safe vaccines. This happened despite this vaccine being developed over a much longer time and more time being available to find out safety risks as well as identify groups of higher risk- susceptibility. ADE was mentioned as an important factor in these serious side-effects. 

The Times of India ( April 4 2021) reported on the AstraZeneca Vaccine ( news report titled More Countries Limit Use of Astra Vax Over Safety Concerns—“More than a dozen countries have at one time suspended or partially suspended use of the shot, first on concerns about efficacy in older people, and on worries  about rare side effects in younger people… The vaccine—developed with Oxford University—has been plagued by safety concerns and supply woes since Phase 3 trial results were published in December .”  

The USA has a system called VAERS for reporting adverse impacts of  vaccines, and even though this system has been criticized by official studies for very substantial underreporting of the actual adverse impacts, still it is important that under this system , for the period December 14 2020  to May 7 ( less than 5 months ) following Covid vaccines as many as 4057 deaths, 17,190 serious injuries and 192,954 total adverse events were reported. While it will take more detailed investigation to fully confirm any causal relationship, it is nevertheless significant that 24% of deaths occurred within 48 hours of vaccination, and 38% of deaths took place among people who became ill within 48 hours of vaccination.

Indian data at an earlier stage was summarized by R. Kumar, President of Society for Promotion of Ethical and Affordable Healthcare, in an article published in the Tribune dated April 14 2021, titled Variants making battle against the virus tougher—“ A presentation made to the National AEFI ( Adverse Event Following Immunization) Committee on March 31 recorded that there had been 180 deaths and over 700 serious  adverse events till that time and three-fourths of the deaths had happened within three days of the shot.” Further this article stated, “ Paradoxically the virus graph started rising after the vaccination graph started  in January. Why? Nobody is sure about the reasons. The fact that immune-escape mutants do not get neutralized by available  vaccines has put a question mark over the mass vaccination drive.”   

AstraZeneca issued a license to the Serum Institute of India to produce its COVID-19 vaccine. AP Photo/Rafiq Maqbool
AstraZeneca issued a license to the Serum Institute of India to produce its COVID-19 vaccine.

The gap between two doses of Covishield vaccine in India was first announced officially to be 28 days ( four weeks). Then after about 3 months the Union government announced in March 2021 that this should be changed to 6 to 8 weeks. Then again on May 13 the Union government announced that this should be changed to 12-16 weeks. As more and more Covid vaccines appear it will be challenge to decide accurately and communicate widely and firmly the gap for various  double dose vaccines. Then it has to be ensured that the second dose is definitely  available in time at all places including very remote places. 

Then there is the additional question regarding the impact on a patient who may get the first dose of one Covid vaccine and the second dose of another vaccine.  The Indian Express quoted a leading  immunologist Dr. Vineeta Bal on this issue ( May 14 2021 ) –Since all vaccine development efforts were carried out independently, there is no data to make a statement  about  whether two different vaccines can be used for two doses. The problem of coordination , in fact, will worsen with more vaccines becoming available.

The Chair of the WHO working group on COVID-19 vaccine, Philip Krause stated recently—The not so good news is that the rapid escalation of these ( new) variants suggests that it is possible for the virus to evolve into a vaccine resistant phenotype, this may happen sooner rather than we like.” This statement obviously contains a very important possibility that may already be unfolding, even though the  scientist has used the style of  an understatement.

WHO director-general Tedros Adhanom Ghebreyesu
WHO director-general Tedros Adhanom Ghebreyesu | Image – WHO@Twitter

In another recent statement around the same time Maria Van Kerkhove , the WHO’s Technical Head for Covid said that a new more transmissible variant may be able to evade some of the protections provided by vaccines, and a surprising number of patients who have already been vaccinated have been found to be infected with the strain.

People who get infected with Covid-19 even after getting a vaccine shot are known as breakthrough cases. The Indian Express reported on May 12, 2021 ( Chandigarh edition)–A small-scale study in health workers  at a private hospital in Delhi  found that breakthrough infections occurred in 13.3 per cent of them ( about 1 in 7 ).

R.Kumar (quoted earlier too), wrote in the Tribune ( April 14, 2021), “ Delhi’s  Sir Ganga Ram’s ( a leading  reputed hospital) 37 doctors have tested positive  for Covid despite vaccination. Similarly . KG Medical College Lucknow has reported 39 corona virus cases of faculty members after full vaccination. Is it a cause-and-effect relationship?”

Another important aspect that needs to be sorted out is whether the various Covid vaccines have been prepared keeping in view the possibility that this virus may not have come from naturally transmission processes and the possibility of this being a lab construct or a genetically altered virus is quite high. What is the difference in a vaccine prepared for a disease related to a virus which infects by natural processes , and a vaccine needed for a disease caused by a lab- created, genetically engineered virus?  We should answer this question satisfactorily before committing our near future so much to many Covid vaccines with all their implications and complications.

The Covid19 Vaccine discourse is just now dominated by how to take it fast forward ( with both governments and opposition parties in overdrive mode) and together with very powerful interests  an attempt is made to create a consensus on the issue with no dissenting voices allowed. As a result the questions raise here have been getting only marginal attention, the main emphasis in policy as well as in media is to just rush up the  Covid19 vaccines in unprecedented ways. Success is measured in vaccines supplied and given. It is important to have a much more comprehensive, multi-dimensional, nuanced,  democratic, evidence-based, well-informed  and above all transparent discourse,  in which all the relevant aspects are given the due attention and there are proper priorities. This is very important to avoid costly mistakes—costly for budgets as well as , what is certainly much more important, costly for health.

Bharat Dogra is a veteran journalist and author, is Honorary Coordinator of Save the Earth Now Campaign. His journalism work has  been recognized in the form of several prestigious awards. His recent books include Protecting Earth for Children, Planet in Peril and Man Over Machine ( Gandhian ideas for our times). Web site bharatdogra.in

 

  

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