Expert Advice Based On Scientific Study Cannot Be Substituted By A Judgment Of Constitutional Courts: Kerala HC While Upholding 84 Days Dose Interval For Covishield

Reversing a Single Judge decision, the Kerala High Court on Friday delivered a significant decision ruling that the second dose of the COVISHIELD vaccine can only be administered after the prescribed dose interval of 84 days. 

In its 94-paged judgment, a Division Bench of Chief Justice S Manikumar and Justice Shaji P Chaly has elaborated on why the decision of the Centre to decline relaxation of the dose interval was justified: 

"Once it is established that the Government have acted on the basis of such advice, it is for the Government to decide how to go about it, in order to get rid of the emergent COVID-19 pandemic situation, which thus means, such expert advice, on the basis of scientific study, cannot possibly be substituted by a judgment of Constitutional Courts, especially when no materials are produced before the Court to show that the expert and scientific advises given to the Government are hasty, bad or ill-advised."

Factual Background:

To improve the immunity and well-being of their employees and to ensure timely export shipments, the respondent companies purchased and administered the first dose of COVISHIELD vaccine to all their employees and family members in June 2021.

Thereafter, they purchased another 12000 doses of COVISHIELD vaccine from a hospital at their own expense to administer the second dose to their employees. By then, the majority of their employees had completed 40 days after the first dose.

However, as per the protocol, the Covid portal (CoWIN) did not permit the administration of the 2nd dose of the COVISHIELD vaccine before 84 days from the 1st dose.  

Later on, the State issued an order allowing people who wanted to travel aboard to administer their second dose of COVISHIELD vaccine after four to six weeks interval. The companies moved representations to the State seeking similar relaxations in the duration of the dose interval to administer the second dose to their employees. These were, however, not considered. 

The aggrieved respondents moved the Court with similar prayers and the Single Judge allowed the writ petition. The Judge had also directed the authorities to regulate the CoWIN Portal to enable the scheduling of the second dose of the vaccine after 4 weeks from the first dose, for those willing. 

The centre moved the Division Bench challenging the said decision. 

Arguments of the Appellants:

• Although the time gap required between two doses of COVISHIELD was initially 4 to 6 weeks, it was later increased to 45 days and further to 84 days, considering the scientific reports of the National Technical Advisory Group on Immunization (NTAGI) and National Expert Group on Vaccine Administration for Covid-19 (NEGVAC). So the interval of 84 days was not based on any executive decision, but on the basis of clear scientific advice. This increase in dose gap was not due to the non-availability of the vaccine as contended by the respondents.
  
• The relaxation given by the Government to a particular class of persons, who are to go abroad for studies, treatment, employment requirements, and for participation in the Olympic games was based on intelligible differentia and it is a reasonable classification.
• The efficacy of the vaccine would be higher after 84 days, which is admitted by the respondents themselves. However, they claimed that they want early protection of their employees rather than better protection as their fundamental right. 
• The contention advanced by the respondents that the interest of their employees should be protected early cannot be given any credence considering the larger public interest.
• The Centre is empowered under the Disaster Management Act, 2005, to impose reasonable conditions on the administration of vaccines, taking note of the safety precautions that are to be made to protect the life and liberty of the people at large.
• Importantly, it was argued that the vaccine was not private property but Government property since it was funding the manufacturing companies, so they had to be administered in a judicious manner.

"It is not a chattel that can be carried from the hospital after paying money. No doubt, the writ petitioners have paid the amount. But, the vaccine is to be administered through the CoWIN Portal as per the standard norms.. that cannot be jettisoned or that cannot be jeopardized."

Relevant Findings

"...we are of the view that Government of India has acted in terms of the scientific and expert advice, based on the studies conducted by them, and therefore, it is not for the Constitutional Courts, to analyse the intrinsic aspects of the same, in order to arrive at a different conclusion, which is also impermissible in law."

(a) Reasonable Classification

Regarding the question of permitting relaxation for a particular class of people, the Court held that this could not be perceived as an unreasonable classification given the circumstances:

"...approach of the Union Government, cannot be said to be an unreasonable classification, because it was not the intention of the Government to give prioritization of vaccine before 84 days, but its intention is to ensure that if such persons have to travel abroad before 84 days, they are to be administered with the second dose of vaccine, most importantly for the reason that other countries permitted the citizens of other countries to travel abroad, only if both doses of the vaccine are administered."

(b) Extraordinary Circumstances:

"It is an undisputed fact that COVID-19 pandemic is not an ordinary or normal situation prevailing in the country..." 

The Court decided that under normal and ordinary circumstances, especially when there is no compulsion for taking the vaccine, an individual or group of citizens may have the right to contend that they have personal liberty to decide the period during which vaccines are to be administered.

However, in the case on hand, the issue is regulated and controlled by the provisions of Disaster Management Act, 2005, and other special enactments. 

(c) Central Government in Control of Vaccine Regulation

The Division Bench held that even though the vaccine can be purchased by the organisations through hospitals, and administer the same, the control and regulation of the vaccine is still with the CoWIN Portal managed by the Centre which itself is a clear indicator that no citizen can be permitted to activate the process of administering the vaccine on individual interest.

"This we say because, the duration of administering first and second doses of vaccine was varied at different times and finally reached now at 84 days, which is on the basis of advice given by the advisory and expert bodies of the Union of India and for acquiring herd immunity, which can never be seen otherwise than to protect the interest of the nation." 

(d) Detrimental To National Interest

It was found that the direction of the Single Judge to regulate the CoWIN Portal to enable the scheduling of the second dose of COVISHIELD vaccine after four weeks of the first dose, for those who want to accept the second dose, after a period of four weeks, cannot be sustained under law.

"Viewed from that angle, if the CoWIN Portal is to be redefined as directed by the learned Single Judge, it can have a national implication, which would derail or upset the activities controlled and regulated by the Central and State Governments and would be quite detrimental to the interest of the nation."

(e) Individual Freedom Should Give Way To National Interest

The Court noted that once the provisions of the Disaster Management Act, 2005 is invoked by the Government, the individual freedom and interest may have given way to the interest of the citizens of the country at large, failing which, the Government would not be in a position to manage, coordinate, and implement the measures and activities taken for protecting the rights and liberties of the citizens at large, rather than self-centric and individual protection of the rights.

Appearance:

ASGI P. Vijayakumar and Central Government Counsel Jaishankar V. Nair appeared for the appellants while the respondents were represented by Advocate Blaze K. Jose and Senior Government Pleader V. Manu. 

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