Prepare for the shot (Indian Express)

Mains Paper 2: Health 
Prelims level: Drugs Controller General of India 
Mains level: Issues relating to development and management of Social Sector/Services relating to Health

Context:

• The Drugs Controller General of India issued a set of guidelines for pharma companies developing the COVID-19 vaccine.

Expediting process:

• A notable feature of this document is the seemingly low bar on the efficiency of the vaccine candidate in the third phase of the clinical trials.
• The vaccine should “achieve at least 50 per cent efficiency” to be widely deployed.
• Regulators usually demand zero incidence of infection — or close to 100 per cent efficiency — in the final phase of the trials.
• That is one reason it takes years to develop vaccines. But the unprecedentedchallenges posed by the pandemic have pushed scientists and regulators to expediteprocesses.
• Many experts also believe that while a 50 per cent efficiency may not seem an impressive infection prevention rate, it could mitigatethe public health emergency substantially.
• That is why the WHO, the US Food and Drug Administration and the Chinese drug regulator have settled for 50 per cent efficiency in the final phase of the trials.
• There is no disputing their rationale. But medical authorities must also be prepared to deal with the challenges posed by the deployment of a first-generation vaccine on a mass scale.

Close watch:

• The low efficiency parameter means that public health authorities will have to closely track the vaccines from the laboratories to the centres where people receive the first jab.
• The high rate of asymptomatic carriers of the novel coronavirus complicates matters.
• They will have to monitor people receiving the initial shots, generate awareness materials for them and conduct frequent quality audits of the vaccine.
• The US Centers for Disease Control and Prevention has, reportedly, begun working on a monitoring strategy.
• Americans administered the first lot of the vaccine will get daily text messages and e-mails.
• India’s child immunisation experience shows that while the country has made appreciable strides in vaccine delivery, it has much to do when it comes to tracking the health of the inoculated.
• The country could perhaps begin by training a cadre of public health professionals who will counsel people receiving the initial lot of the vaccines and keep regular updates on their health.

Conclusion:

• It’s evident that the first lot of the vaccines will not mean the end of the battle against the novel coronavirus.
• Efforts are underway to develop multiple vaccines. But the country will also need robust data on the working of the initial lot of vaccines.
• It’s imperativethat a mechanism is put in place without delay.
• Before the first vial of COVID-19 vaccine is ready, mechanism to track its progress must be put in place.

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Prelims Questions:

Q.1) With reference to the Methanol, consider the following statements:
1. Rashtriya Chemicals and Fertilizers Ltd (RCF), a PSU under the Ministry of Chemicals and Fertilizers has started its Methanol Plant at Trombay Unit, Mumbai.
2. With this, RCF has entered the select list of Methanol producers in the country, providing alternate to import.

Which of the statements given above is/are correct?
(a) 1 only
(b) 2 only
(c) Both 1 and 2
(d) Neither 1 nor 2

Answer: C

Mains Questions:

Q.1)What are the key guidelines for pharma companies issued by The Drug Controller General of India relating to the developing of COVID-19 vaccine?