By Kamal Pratap Singh
Covaxin approval has been delayed after EUA rejection by FDA which will delay the use of COVAXIN in USA and other countries, instead the FDA has suggested for direct Biologics License Applications BLA or full use. Covaxin Approval from WHO is also pending next month i.e. July 2021.
International travel is also depending on vaccination status, many countries are now using it as a benchmark for allowing vaccinated foreign nationals to travel. Out of the three vaccines approved for use in India, only one—Covishield—features on the emergency use listing (EUL) of the World Health Organization (WHO).
Vaccine lobbying and politicization have been discussed and fairly understood several times in current pandemics of COVID-19. We have also covered news and article that discusses how many reasons other than science play role in decisive factors toward vaccination plannings.
We have seen that studies have been disapproved and even retracted from reputed journals like Lancet and NEJM of various treatments for COVID-19, seen how FDA and WHO’s roles in regulatory approval were criticized after retraction of these papers, seen how vaccine were approved and inoculated on mass scale even without proper approvals, all these just to get ahead in the race of vaccine nationalism and profiteering.
Will it lead to vaccine hesitancy
FDA actions in past and now lead us to think about the most important aspect i.e. vaccine hesitancy, the loss of trust in FDA approved products. I understand that two most important factors which are responsible to increase vaccine hesitancy among population are pharma profiteering and nationalism.
So what if America and Britain who declare themselves as superpowers becomes the largest supplier of vaccine and thus will attract huge money from the global communities that not only limited to national governments but extended to various organizations that are working in healthcare setting around the globe like WHO, GAVI, CEPI etc as seen in recent G7 summit. These organizations have multibillion dollar fund for the purpose of medical aids and these organizations gets funds from national governments of many countries.
Let us take the top three companies first, which are largest manufacturer of COVID-19 vaccines in current times
Others are CanSino; Sinovac; Serum Institute of India, Johnson & Johnson; Sputnik V; Sinopharm; Bharat Biotech etc.
If we see nationalism, AstraZeneca is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters at the Cambridge Biomedical Campus in Cambridge, England and Pfizer is an American multinational pharmaceutical and biotechnology corporation headquartered in Manhattan, New York City both which first got EUA approval from US-FDA or WHO.
According to Baba Ramdev the owner of Patanjali Ayurveda, these western pharma companies work for profits only which they are eager to extend to populous countries like India. Baba Ramdev is not alone in this world with such blames, many other scientists and policy makers have made such claims.
Pharma profiteering to national products is apparent from current action of FDA which does not want an Indian vaccine in USA and thus declined application of BB which is providing lowest cost, most effective vaccine priced after considering humanitarian cause in pandemic and not for profits unlike many of the American and British companies that looks to work exclusively for money.
People vaccinated after Pfizer and Astrazeneca shots have shown side effects including some serious like blood clotting and anaphylaxis but the risks were diluted given the need of vaccine whereas Covaxinated subjects have not reported any side effects till now. The question also arise of phase 3 studies of BB’s Covaxin but 29 million people and 6 months of analysis have not proved as sufficient evidence toward its safety and efficacy. Still, FDA has asked for more COVAXIN trial data to be considered for approval. On the contrary, Covishield which is developed at University of Oxford, manufactured by British company AstraZeneca and sold by SII in India – enjoys approval in Europe as well as with the WHO.
COVAXIN of BB priced at Rs.150 for govt which is the lowest price one can offer. Considering others it is not making significant profit. It could have produced vaccine for world but BB has low manufacturing capacity which should have been increased to 50-100 folds given the opportunity of becoming world’s biggest biologics company from India.
Recently, BB said in a statement that “The supply price of Covaxin to the government of India at Rs 150 / dose, is a non-competitive price and clearly not sustainable in the long run. Hence a higher price in private markets is required to offset part of the costs,” it said in a statement.
SII had earlier given its per dose pricing of its ‘Covishield’ vaccine at ₹150 for the Central government, ₹400 for State governments and ₹600 for private hospitals while Bharat Biotech (which rolls out ‘Covaxin’) had quoted ₹150 for the Centre, ₹600 for State governments ₹1200 for private hospitals. This price difference has also created vaccine hesitancy to a large extent.
Now coming to the profits, in India only, AstraZeneca (British company) has sold 7 times the doses as compared to Covaxin at 213.6 million of Covishield against 29 million dose of Covaxin. And made profits to the tune of these numbers, since Covaxin has supplied mainly to govt. and because of delay of international approval it is not able to export to other countries which all lead to short supply of safest vaccine. Without being approved by the WHO or the FDA, Covaxin is unlikely to be accepted as a legitimate vaccine by many countries.
COVAXIN has also got the least funding from investors since the starting of its R&D programs whereas astrazeneca, Pfizer, SII have received huge amount for their vaccine discovery and manufacturing programs from institutions like national govt departments, philanthropic organizations etc.
Preferentially safe COVAXIN which is a whole inactivated virus vaccine is little costly to produce given inoculation and purification step that should be carried out in BSL-3 facility which itself is costly to built. Last week, the regulator in Brazil announced that Bharat Biotech would be allowed to import and administer Covaxin in the country, but with strict conditions of manufacturing, quality-control and delivery. It also restricted the import to 4 million doses, instead of the original 20 million.
On June 9, Bharat Biotech also announced that it would conduct phase 4 clinical trials of Covaxin, to assess the beleaguered vaccine’s real-world effectiveness. The company also added that data from the phase 3 trials would be available only in July, and not June as it had said earlier.
Thus far, India has administered 242.6 million vaccine doses – 213.6 million of Covishield and 29 million of Covaxin. As of June 9 morning, 14% of Indians have received at least one doses of either vaccine and 3.3% have received both doses.
It is also to be noted that recently American Pfizer has not been granted approval in India when it was willing to donate 5 billion doses to India, though it demanded indemnity too, after which SII had also demanded the same.