Pandemic – Vaccination – Indemnity
Indemnity against vaccines during a pandemic
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- The sum of money paid as compensation, especially by a country as security or protection against a loss or other financial burden is called an indemnity.
- Upon vaccination, if someone develops any serious side effects the manufacturer might face legal troubles. If those numbers are huge the labs that produce vaccines might not be able to deal with those liabilities on their own.
- Large Foreign pharmaceutical manufacturers tend to share/ arm-twist that risk with local governments. Some have agreed while some like India have not, until now.
- Manufacturers sought indemnity mentioning the harried pace of vaccine development at a time when side effects were unknown.
- GOI issues Emergency Use Authorisation for Covishield and Covaxin after negligible side effects were observed and no risk of any significance was found when tested on thousands of people.
- First priority was for immunizing 3 crore healthcare and frontline workers in the first phase of the nationwide vaccination drive beginning Jan 16th.
- Last year Pune based Serum Institute of India (SII) enters into a manufacturing partnership with AstraZeneca (a British-Swedish multinational pharmaceutical with its headquarters in Cambridge, England) to produce (in India) and supply 1 billion doses of the Covishield vaccine developed by Oxford University.
- 12th Jan 2021, trucks rolled out of the SII at 5 am for Pune airport loaded with their first consignment and were flown to Delhi, Ahmedabad, Kolkata, Chennai, Bengaluru, Karnal, Hyderabad, Vijayawada, Guwahati, Lucknow, Chandigarh, and Bhubaneswar.
- Hyderabad-based Bharat Biotech developed the Covaxin vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
- 13th Jan 2021, Bharat Biotech shipped Covaxin to Ganavaram, Guwahati, Patna, Delhi, Kurukshetra, Bangalore, Pune, Bhubaneswar, Jaipur, Chennai, and Lucknow.
History of indemnity in India
- SII wanted indemnity for Covishield before it launched the same in India.
- CEO Adar Poonawalla said that an indemnity clause during the period of the pandemic would ensure the vaccination drive did not halt if there was an injunction (judicial order compelling to compensate for injury or loss to an injured party)
- Jan 2021 nationwide vaccination drive was rolled out but no indemnity was given to SII or Bharat Biotech. Since the vaccination was voluntary, implied consent (one understands the risks and benefits) was considered making indemnity void.
Raw materials shortage in India
- In Nov 2020, quoting a shortage of raw materials American pharmaceutical giant Pfizer Inc. halved its BioNTech vaccine production estimates from 1.2 billion shots in 2021 to 600 million doses.
- Joe Biden’s poll promise included 100 million vaccination shots in his first 100 days in office. The US government has ordered 600 million doses of Covid-19 vaccines from both Pfizer Inc. and another US supplier, Moderna Inc. Delivery was supposed to happen in regular increments by the end of July 2021.
- One of the first moves of the new Biden administration after coming to power in Jan 2021 was to invoke a Defense Production Act (DPA). This act gave the state the power to control the distribution of raw materials critical for vaccine production.
- Biden aimed to hasten vaccine production in his country at the expense of developing counties like India. His administration had assured SII & India of an uninterrupted supply of raw materials but had backed out.
- Poonawalla With ‘folded hands’ urged Biden to lift the export ban of raw materials. He said that finding new suppliers in the eleventh hour would delay our production
Supply affected in India
- SII imports include filters, bags, and adjuvant from the US. Vaccine cells are grown in large sterile plastic bags. Adjuvants are used to increase the effectiveness of vaccines and boosts antibody growth in our immune system.
- New suppliers had to be organized for filters and sterile plastic bags but not adjuvants. Any change in the vendor of that adjuvant would mean fresh clinical trials and approvals.
- During the second wave in India, the US administration agreed to provide “specific raw materials” for the manufacture of Covishield vaccines. Serum Institute still continued to face shortages of supplies from the US.
- Bharat Biotech tied up with the Council of Scientific and Industrial Research (CSIR) to work on technologies for producing raw materials in India. They are less reliant on the US ones and their European Union suppliers did not stop supply.
Change in policy
- India is looking to step up imports and expand its supplies. The Russian-made Sputnik V vaccine was approved for use in April following which three million doses were supplied by Russia. Currently being made in India, local supplies are expected by next month.
- The government of India (GOI) recently allowed the import of vaccines approved by the United States Food and Drug Administration (USFDA), the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), as well as those on the emergency use list of the World Health Organization (WHO).
- Pfizer now says it has orders to supply 1.6 billion doses in 2021 and has the capacity to make 2.5 billion meaning it has doses to spare/ sell. It also aims to boost its capacity to more than 3 billion doses in 2022 and now wants to deal with the GOI.
Terms and conditions
- They wanted Indian regulators to bypass local clinical trials (bridge trials) and GOI waived them off this month.
- By indemnity, Pfizer and Moderna want to recover damages from GOI if and when a court orders to pay damages to someone who suffers an adverse event (a side effect or health complication)
- Pfizer wants judgments on disputes that might arise from its vaccines sold in India to be settled in US courts.
- NITI Aayog member (Health) Dr V K Paul’s said recently that in the interest of the nation and people, no such decisions to grant indemnity to any foreign or Indian Covid vaccine company have been taken.
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- Vaccines reach the central drug laboratory at Kasauli in Himachal Pradesh after 45 days from the time production begins. They are then dispatched to hospitals across India.
- Both PM Narendra Modi and Foreign Minister S Jaishankar have negotiated with the Biden administration to ease the restraints on raw material exports needed for the manufacture of vaccines from that country.
- Those materials were taken out of the DFA purview last week. This should enable unrestricted export without approval from US authorities. This will also speed up the SII production of Covishield.
- Indian states where production facilities are located and which had local issues have been resolved and should ensure increased production.
- There are rumors that SII has solicited indemnity from the GOI. SII negotiated its supply deal with the government in January and to ask for it five months after closing a deal does not make sense. Out of 35000 crores, allocated for this financial, SII was paid 3000 and Bharat Biotech 1500 crores respectively as advance.