Where Does the World Stand for Effective Corona Vaccines?
Corona infection SARS nCoV2 virus has been tormenting the world now for nearly 1 year after the 1st case occurred on 17 Nov in Wuhan China. It is widely believed that the virus is not natural but a modified one which caused infection either accidentally or as a result of covert trial by the PLA. Covert trials of Biowarfare agents are known to have taken place in many countries in the past and there is no reason to negate this possibility. There are many possibilities that this virus came from Wuhan Lab as mentioned below: -
- The virus from a patient was first isolated and identified on 07 Jan 20.
- The genome of this virus was released on 09 Jan 20 by the Chinese administration. A Chinese scientist Ming Li associated with Wuhan lab later identifies that the genome released earlier is identical with the Covid19 virus.
- The Covid19 RT-PCR detection kit was available commercially in Wuhan Hospital on 16 Jan 20.
- The strain of the virus at Wuhan Lab, among Covid19 patients in Wuhan as well as the world over are identical. Only recently, a slightly different variant has been identified in Europe.
All of a sudden, after the US Election, the two American countries have sent a bolt from the blue… that their Pfizer and Moderna vaccines are ready. They have claimed >90% efficacy and trying to project as if USA is ready with all infra & service set-up as on yesterday. In this race of ‘marketing one upmanship’, no one wants to be left behind. Russians have put-up their claim once again…of high efficacy of their Sputnik-V vaccine. The British too, have gone in a high marketing hype that their Oxford-AstraZeneca has high efficacy of 70-90%. Two Indian companies, Covaccine and Covishield, are not lagging much behind claiming to be in the final stages of their Ph-3 vaccine trials.
1. Pfizer, which is developing a vaccine in partnership with Germany’s BioNTech SE, said the -candidate- BNT162b2-was found to be 95% effective in the final analysis of its phase 3 trials. Moderna are claiming 90% efficacy. However, both Pfizer & Moderna vaccine will be a huge challenge for India as it needs to be stored and transported at -700 and -800 Celsius respectively lest its potency will fall drastically. In India, such strict extreme cold-chain may not be feasible. Both companies are expected to apply for emergency use authorisation (EUA) to the FDA. These two vaccine candidates have to submit their entire trial reports to the FDA by mid December 2020 in order to get the EUA.
2. Sputnik-V of Russia had claimed a premature go-ahead for the vaccination, has subsequently undergone extensive trials in many countries. Many senior ranking officials were see taking this vaccine.be tested in a ‘Joint Indo-Russian Trial’ at Kanpur Ganesh Shankar Vidyarthi Medical College as per agreement signed between Dr Reddy’s Lab and the Russian Foreign Direct Investment (RFDI). In the heat of the marketing preferences, this vaccine too should be ready anytime now. The cold chain is at -200 C; not as stringent as Pfizer or Moderna.
3. AstraZeneca-Oxford's coronavirus vaccine too will not like to be left behind in the marketing. They had suffered some serious side-effects during the trials which had to be interrupted. They claim to be as safe now but comprehensive study of the data by the regulator FDA has to be undertaken. Its efficacy is being claimed at 62-90% depending upon the dose schedule. This result has also struck a controversy about the real efficacy. It was clarified by their officials that 2,800 participants received the smaller dosing regimen (first half dose followed by full dose a month later) showed 90% efficacy as compared with nearly 8,900 participants who received single full dose, providing 62% efficacy for reasons unknown. This has created doubts in some quarters. They have not yet applied for EUA. The same vaccine seeds were taken by Serum Institute of India as Covishield with slightly different technology and is nearing Ph-3 trails in 2-dosage schedule. Iitial claim is approx. 75% efficacy. As and when the approval is accorded to Oxford AstraZeneca, Covishield too may get clearance soon.
4. Johnson and Johnson-owned Janssen Pharmaceutical vaccine has entered phase 3 trials with 20% of the participants under 40 years and 30% above 60-year age.
5. Shanvac and CoronaVac of China is being developed under the veil of secrecy of the Chinese military without much data being shared to the public. The nations which are under Chinese financial obligation, will be thrust upon this vaccine irrespective of its efficacies or approval. They are unlikely to seek approval of the international drug controllers. Democratic Nation may not fall prey to the Chinese nefarious designs. India is unlikely to go for it esp when two of its own vaccines are nearing completion of the trials.
6. Covaccin, being developed indigenously by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) is nearing Ph-3 trials. It is our own R&D under the directive of the ICMR.
7. Covovac: Serum Institute of India has received the bulk vaccine and Matrix-M adjuvant from Novavax (US). This vaccine formulated at SII (COVOVAX) will be tested in a Phase 3 trial in India and an application for the same to regulatory authorities will be made soon by ICMR and SII. It has already started Ph-3 trials at UK, UV & South Africa. India too is in the process thru’ its own development through Serum Institute.
There are five vaccine candidates being tried out in India. These include Serum Institute vaccine,Bharat Biotech, Zydus Cadila has just started phase-3 trials. Besides, Russian Sputnik -V being tested in collaboration with Dr Reddy’s Lab as well as Biological E will be entering Ph-3 trials soon.
In order to keep a reliability check on the various vaccines being used in India, General Specifications, GS1 India, a Standards Organisation set up by the Ministry of Commerce, is emphasising the tracking of each of the vaccines as it moves across the supply chain. It is extremely important as patient safety is the key driver for adopting these standards. GS1 is working with Serum institute of India, Bharat Biotech, Dr. Reddy’s laboratories and Zydus Cadila for vaccine chain traceability. “At the manufacturing point itself, there needs to be an IT-enabled mechanism. Besides, unique global product identifier (GTIN), date of expiry, batch number needs to be captured at the secondary packaging level and unique carton code (serial shipping container code) at the tertiary packaging level provide a credible monitoring of the supply chain.
Time is running out for the Corona vaccines. The virus is believed to be changing its antigenicity and strains. Two variants of the virus have already emerged in Europe (called SARS-Cov-2, D614G and 20A.EU1). Whether these variants could be prevented equally effectively from causing the disease, remains to be seen. It is an unusual time of the Covid19 pandemic that has already claimed more than million lives. Hence, the world drug certification/approval fraternity be it FDA or anyone else, must be proactive to put them to the use if found effective. Long process of certification and approval can be shortened in these unusual testing times. Emergency Use Authorisation (EUA) of vaccination needs to be explored to protect the humanity.
This is also a time when commercial pressure by powerful lobbies, be it USA, China or Russia, may be applied to buy their products that has huge cost factor and financial consequences. The pressure may also be applied by them to derail other vaccine developments. Hence, we Indians (ICMR & Covid Task Force under PMO) must safeguard our own interest for our 1.38 billion population and work overtime to get approval for our vaccine too for the mass usage…either fully certified or under EAP. The cost factor of the vaccination will be huge. US vaccines (Pfizer/Moderna) are putting their price tags of about $20-30 per dosage. Russian Sputnik-V is tentatively being priced at less than $ 10 per dosage. Oxford-AstraZeneca is likely to be priced at Euro 2.5 per dosage. Indian version of this vaccines ‘Covishield’ too is likely to be comparatively cheaper. Serum Institute CEO expressed to the PM Narendra Modi on 28 Nov 20 during his visit that they intend to price it for the Indian govt at Rs 250/- per dose and to the private users at Rs 1000/- per dose. They are confident of manufacturing 100 million doses by January and hundreds of million could be ready by the end of February 2021. It will be an India first policy of distribution…just as vaccine candidates of other nation will have for themselves first. However, in a country like India that needs approx 2 x 1.38 billion dosage, the cumulative cost will be phenomenal. Hence, a logical approach to the mass vaccination is likely to be followed. Some state govts of India are contemplating provide free vaccine to their citizen. Some Vaccine developing countries have offered a royalty-less offering of ToT under license till the period of the pandemic. Russians have offered all their nationals a free of cost vaccination. Hence, the financial/economic implications of the vaccination are going to be varying for different nations.
The world humanity is looking forward to the vaccines to provide a relief from the pandemic. The nation which is culpable must not be let to get away. The SARS nCoV2 was in all probability is a modified virus that has unprecedented virulence, which is largely responsible for the spread of the disease. World must join hands together to fix the culpability and if so confirmed, must seek the compensations to each and every victim. Actually this action was to be initiated by the WHO but possibly its Director General Dr Tedros has closed his eyes from his responsibility. Then it is for the individual nations to implicate WHO and seek accountability.
Although it is difficult to believe China, WHO emergency director Michael Ryan has announced that the Chinese have agreed investigation in the “animal origin” of the virus. What does it mean? Will the investigating team will only look in to the animal origin of Corona virus and not investigate the Wuhan Virus Lab link? Wuhan Virus Lab P4 was known to be working with modified bat virus that accidently or otherwise came out to cause Covid19 devastation. The investigation team must be provided an open mandate to go in to all such angles of the virus in question and not be merely an eye wash for the world community. The investigation team must constitute of world known epidemiologists, virologist, nuclear biologist, Biowarfare specialists along with some others such as specialist in community medicine, immunologists and others.
Availability of Vaccines in India
It looks apparently sure that the two US vaccines Pfizer & Moderna will get approval under EUA in the coming days or weeks. Even Oxford-AstraZeneca is in the same line. Indian Covishield having same viral seeds as Oxford-AstraZeneca but adopting slightly different technology and process too, should be in line for EUA approval. Russian Sputnik-V too may seek approval for EUA. Hence, all above vaccine candidates will be ready with full or conditional approvals in the coming weeks or may be month(s). Indian Covaccine is also likely to seek EUA a week or two later than Covishield.
Any vaccine candidate will have to first meet their own obligation to their own nations and citizen. Hence, even if India places demand for it on the US or Russia, the supply can be made only after they have made it bulk available to their own populations…taking a month or two at least. In that 1-2 month(s), even the Indian vaccine (at least Covishield) will be ready with EUA. Hence, the govt as well as the private agencies must bear in their minds about the availability of the vaccines before placing their demands. Next, it is the stringent cold chain of -70 to -80 deg C for the American Vaccines and -20 deg C for the Russian vaccines that will have to be put in place which is a very difficult ask…esp in the non-metro cities. Such facilities of cold chain have to be in the transporting aircraft as well. Any compromise in the cold chain will adversely affect the efficacies of the vaccines that will be not known to the people or the agencies unless the vaccine-failures are found months later.
India already has a well-established Cold-Chain infrastructure in place all over India incl rural areas for other vaccinations under ‘Indra-dhanush’ scheme which same as Covaccine/Covishield. Hence, one may have to really think if it would be worth to Import the American or Russian vaccines from abroad requiring another expansive and illogically stringent cold-chain infrastructure that is very stringent, difficult and likely to fail. On the other hand, Covishield, Covaccine and Oxford vaccines are suited for Indian conditions. Oxford vaccine will be manufactured in India and there is already some sort of MoU to divert some percentage of the vaccines to the Indian users. Time will tell us how all these will be impacting the vaccination effort.
Considerations in the Covid19 Vaccination Plan for India
Numbers below are tentative, of the 138 Cr population of India.
No vaccination of Pregnant Women (10% of all = 6.6 Cr) & Children below 5 yrs 12% (16.5 Cr)=23.1 Cr
Children from 5-14 yrs whose vaccination dose have not yet decided=23.3% of 138 Cr=32.2 Cr
People already infected, could be vaccinated at a later date=1 Cr
Remaining number of individuals to be vaccinated = 81.7 Cr
Vaccine available in first month = 10 Cr dose from Covishield + 2 Cr from other Mfrs (oxford).
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First priority: Covid warriors (~3 Cr) may be vaccinated with doses from Oxford Vaccine Manufacturing MoU
Second priority: Elderly >60 yrs = Total about 11 Cr of which 6-7 Cr in Covid Green zones be vaccinated later.
Third priority to working class…going to offices, institutions & business work, labours in close spaces
Fourth priority: remaining individuals, students of school & colleges, trainees, apprentices, other labours
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Booster dose after 1 month of first dose… will have to be with same candidate vaccine as first dose.
By this time Covaccine may also be available.