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DCGI shares draft guidelines for pharma giants manufacturing, distributing COVID-19 vaccines

DCGI shares draft guidelines for pharma giants manufacturing, distributing COVID-19 vaccines 1

Dr Balram Bhargava, Director-General of ICMR said, ‘There are three things for a vaccine–(i) the safety, (ii) immunogenicity, and (iii) the efficacy.’

DCGI shares draft guidelines for pharma giants manufacturing, distributing COVID-19 vaccines

Records of who has received the vaccine, lot number of the vaccine, scheduled for next dose and adverse effects, if any, will have to be maintained diligently. Image credit: CDC

The Drugs Controller General of India (DCGI) has issued new guidelines to ensure that when a safe and vaccine COVID-19 vaccine is distributed, its effectiveness and safety are maintained for everyone to use. There are over a dozen pharma companies in India that are in a race to develop Indian vaccines against the coronavirus. The new guidelines are aimed at ensuring they have a clear understanding of the regulations to be followed in manufacturing and distribution of a potential vaccine.

The DCGI, under the Central Drugs Standard Control Organization, is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines, and sera in India.

A circular signed by the serving DCGI, Dr V G Somani, states that the guidelines are not replacing any ‘statutory requirements’ but are merely recommendations. The pharma industry has been given an opportunity to voice their suggestions or disagreements to the guidelines up until 12 October 2020, after which the DCGI and the CDSCO may choose to modify the guidelines accordingly.

When asked about the efficacy of COVID-19 vaccine, Dr Balram Bhargava, Director-General of ICMR said, “There are three things for a vaccine–(i) the safety, (ii) immunogenicity, and (iii) the efficacy. Even, WHO says that if we can get more than 50 per cent efficacy that is an accepted vaccine.

“For respiratory viruses, we never get 100 percent efficacy. We are aiming for 100 percent efficacy but may get 50-100 percent,” he added.

Key highlights from the draft guidelines

1. The COVID-19 vaccine candidate should have at least 50 percent of efficacy in the Phase-III clinical trial for it to be widely deployed.

2. Adequate data about the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD) needs to be generated.

3. The vaccines are well-characterised, and manufactured consistently.

4. The COVID-19 preventive vaccines must take into account pregnant women and those with childbearing potential.

5. COVID-19 vaccine trials should periodically be monitored for unfavourable imbalances between vaccine and control groups in COVID-19 disease outcomes, in particular for cases of moderate to severe COVID-19 that may be a signal for vaccine-associated ERD.

6. The studies should include pre-specified criteria for halting based on signals of potential vaccine-associated ERD.

7. The draft recommends that the pharmaceutical companies use an independent Data Safety Monitoring Board (DSMB) for vaccine-associated ERD and other safety signal monitoring, especially during later-stage development.

8. People who have been previously infected should be included at the testing stage of the vaccine, as long as they do not have acute Covid-19 or other acute infectious illnesses.

9. If a trial fails to meet the predefined criteria for superiority or non-inferiority with respect to any of the antigenic components, the possible reasons for the result and the clinical implications of it should be carefully considered before proceeding with clinical development or licensure, noted the guidance.

(Non-inferiority randomized controlled trials aim to demonstrate that a new treatment is no worse than a comparator that has already shown its efficacy over placebo within a pre-specified margin. However, clear guidelines on how the NI margin should be determined are lacking for vaccine trials.)

10. The draft suggests that it may be easier for globally tested candidates like the AstraZeneca-University of Oxford and Russia’s Sputnik V vaccine to receive approvals here on the basis of testing data generated in other countries. An additional local trial “may” be required.

11. The DGCI has also asked pharma companies to present a final analysis plan before closing the trail database. “This should include any planned interim analyses, which should be adequately addressed in terms of purpose, timing, and any statistical adjustments required,” the guideline said.



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