Vaccine shortage, pending approvals, abdication of responsibility – Centre busts myths on Covid-19 vaccination

Several myths surrounding India’s Covid-19 vaccination programme have been doing the rounds. These myths are arising due to distorted statements, half-truths and blatant lies, the central government said on Thursday.

Dr Vinod Paul, Member (Health) in NITI Aayog and Chair of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), bust these myths and gave out the truth on these issues.

India is currently at an advanced stage of the vaccination process against the Covid-19 virus, with two indigenous vaccines – Covishield and Covaxin – along with Russian-made Sputnik V being administered to people across the country.

Myth 1: The Centre is not doing enough to procure vaccines from abroad

Fact: The central government has constantly remained engaged with all major international vaccine manufacturers right from mid-2020. Multiple rounds of discussions have happened with Pfizer, J&J and Moderna. The government has offered all assistance to have them supply and /or manufacture their vaccines in India.

However, it is not that their vaccines are available in free supply. We need to understand that buying vaccines internationally is not similar to buying ‘off the shelf’ items. Vaccines are in limited supply globally, and companies have their own priorities, game-plans and compulsions in allocating finite stocks. They also give preference to countries of their origin just as our own vaccine makers have done unhesitatingly for us.

As soon as Pfizer indicated vaccine availability, the central government and the company began working together for the earliest possible import of the vaccine. As a result of these efforts, the Sputnik V vaccine trials got accelerated and with timely approval, Russia has already sent two tranches of vaccines and accomplished tech-transfer to our companies that would start manufacturing very soon. We reiterate our request to all international vaccine makers to come and make in India – for India and for the world.

Myth 2: The Centre has not approved vaccines available globally

Fact: The central government has proactively eased entry of vaccines approved by US FDA, EMA, UK's MHRA and Japan’s PMDA, and WHO’s Emergency Use Listing into India in April. These vaccines will not need to undergo prior bridging trials. The provision has now been further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries. No application of any foreign manufacturer for approval is pending with the drugs controller.

Myth 3: The Centre is not doing enough to ramp up domestic production of vaccines

Fact: The government is playing the role of an effective facilitator to enable more companies to produce vaccines from the early 2020. There is only 1 Indian company (Bharat Biotech) which has the IP. The government of India has ensured that 3 other companies/plants will start production of Covaxin apart from enhancing Bharat Biotech’s own plants, which have increased from 1 to 4.

Covaxin production by Bharat Biotech is being increased from under 1 crore per month to 10 crore month by October. Additionally, the three PSUs will together aim to produce up to 4.0 crore doses by December. Serum Institute too is ramping up Covishield production from 6.5 crore doses per month to 11.0 crore doses per month.

The Centre is also ensuring a partnership with Russia so that Sputnik V is manufactured by 6 companies coordinated by Dr Reddy’s. The Union government is supporting efforts of Zydus Cadila, BioE as well as Gennova for their respective indigenous vaccines through liberal funding under Covid Suraksha scheme, as also the technical support at national laboratories.

Development of Bharat Biotech’s single dose intranasal vaccine is proceeding well, and it could be a game-changer for the world. The estimate of production of over 200 crore doses by our vaccine industry by the end of 2021 is the result of such efforts and unstinted support and partnership.

Myth 4: The Centre should invoke compulsory licensing

Fact: Compulsory licensing is not a very attractive option since it is not a ‘formula’ that matters, but active partnership, training of human resources, sourcing of raw materials and highest levels of bio-safety labs which is required. Tech transfer is the key and that remains in the hands of the company that has carried out R&D.

In fact, India has gone one step ahead of Compulsory Licensing and is ensuring active partnership between Bharat Biotech and 3 other entities to enhance production of Covaxin. Similar mechanism is being followed for Sputnik.

Moderna had said in October 2020 that it will not sue any company which makes its vaccines, but still not one company has done it, which shows licensing is the least of the issues.

Myth 5: The Centre has abdicated its responsibility to the states

Fact: The central government is doing all the heavy-lifting, from funding vaccine manufacturers to giving them quick approvals to ramping up production to bringing foreign vaccines to India. The vaccine procured by the Centre is supplied wholly to the states for free administration to people. All this is very much in the knowledge of the states. The government has merely enabled states to try procuring vaccines on their own, on their explicit requests. The states very well knew the production capacity in the country and what the difficulties are in procuring vaccines directly from abroad.

In fact, the Centre ran the entire vaccine program from January to April and it was quite well-administrated compared to the situation in May. But states that had not even achieved good coverage of healthcare workers and frontline workers in 3 months wanted to open up the process of vaccination and wanted more decentralisation.

Health is a state subject and the liberalised vaccine policy was a result of the incessant requests being made by the states to give them more power. The fact that global tenders have not given any results only reaffirm what we have been telling the states from day one: that vaccines are in short supply in the world and it is not easy to procure them at short notice.

Myth 6: The Centre is not giving enough vaccines to the states

Fact: The central government is allotting enough vaccines to the states in a transparent manner as per agreed guidelines. In fact, states are also being informed in advance of the vaccine availability.

Vaccine availability is going to increase in near future and much more supply would be possible. In the non-government channels, states are getting 25% of the doses and private hospitals are getting 25% doses.

However the hiccups and issues faced by the people in the administration of these 25% doses by the states leave a lot to be desired.

Myth 7: The Centre is not taking any step to vaccinate children

Fact: As of now, no country in the world is giving vaccines to children. Also, the WHO has no recommendation on vaccinating children. There have been studies about safety of vaccines in children, which have been encouraging. Trials in children in India are also going to begin soon.

However, vaccinating children should not be decided on the basis of panic in WhatsApp groups and because some politicians want to play politics. It has to be a decision taken by our scientists after adequate data is available based on trials.

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