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Understanding Laws for Approval of Vaccines and Its Flexibility during Pandemics

INTRODUCTION :

Corona is a large group of viruses that cause illness in humans and animals. Rarely, animal corona viruses evolve and infect humans and then spread within the human race as seen in the cases of MERS and SARS.

The outbreak of novel corona virus disease (COVID-19), initially noticed in a seafood market in Wuhan city in China in mid-December, 2019, has now, spread to 214 countries/territories/areas worldwide[1]. World Health Organization has declared COVID-19 as a pandemic on 11th March, 2020. “At present, the therapies that are used to treat affected patients is based on a limited available evidence. As the situation evolves and when more data become available, the evidence will be accordingly incorporated”, says the government of India in the protocol released on June 27th 2020.

ROLE OF VACCINES :

With this virus sickening and killing thousands around the world, the public are done anticipating the end of the lockdown. But, without a vaccine against corona virus, we’re always at a risk of another devastating outbreak of the disease. While, vigorous testing and quarantining procedures definitely help control the spread, the only way to glaringly reduce the threat is, if a sufficient population is immune to the virus, such that, they cannot pass it.

Currently, approx. 2-14% might be immune to the virus[2] (slightly more in certain cities), but the above can only be achieved if around 60% of the population becomes immune. Such community or heard immunity can be achieved either if a humungous number of people get infected by the virus, which costs lives and is awfully risky or, through vaccination.

In India, vaccine related research projects are carried out and implemented in a number of institutions like, Indian Council of Medical Research (ICMR), Department of Science and Technology (DST), Council for Scientific and Industrial Research (CSIR), various autonomous institutions supported by the Department of Biotechnology (DBT), small and medium vaccine industries & Medical and Engineering schools[3]. These institutions, receive advice from the National Technical Advisory Group on Immunization (NTAGI), a group of experts in the field of vaccination and immunization. NTAGI meets on a regular basis and deliberates various technical and policy decisions related to immunization program in India.

DEVELOPMENT OF VACCINE – PHASES AND APPROVALS :

A vaccine normally takes 5-10 years to be approved and available for public administration. The two most important goals of every vaccine are, safety and efficacy[4]

Primarily, the vaccines administered to the people must be safe. Some minor side effects like, a mild fever or pain in the site of injection can be acceptable, but injecting people with something that makes them sick is unethical. Efficacy measures the extent to which the vaccine protects the public from contracting the specific disease. Although one would ideally want a vaccine to be a 100% efficient, its not always the case.

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To screen for safety and efficacy, every vaccine goes through three phases of trials:

  1. Phase one:  Firstly, different dosages of the vaccine are administered to a small group of healthy volunteers to determine the ideal dosage that invokes the strongest immune response, without serious side effects.
  2. Phase two: This time, hundreds of people get the vaccine. This cohort will include people of different ages and health reputes. The response in each of them will be studied and analysed.
  3. Phase three:  Finally, the vaccine is given to thousands of candidates. This is usually the longest phase, because it occurs in a “Natural Disease Condition”. The vaccine is introduced to a large group of people, who are already at the risk of infection by the target pathogen, to see if the vaccine reduces the number that get infected.

Once, the vaccine clears all three trial phases, it gets submitted to the WHO and various government agencies for approval, while the organization gets ready to manufacture the same.

CREATING A VACCINE IN A HISTORICALLY FAST TIME :

Despite the fact that this timeline has worked wonders in the past, in today’s scenario, every day we cut from this process, will unquestionably make a huge difference to the world in terms of, saving numerous lives and in preventing trillion bucks worth economic damage. “It normally takes five to ten years for a vaccine to be approved for market use, but during a pandemic, this timeline may be compressed”, says, Dr Jerome Kim, head of the International Vaccine Institute[5].

The Drugs and Cosmetics Act, of 1940 was amended in 2008. According to the section 26B of the Drugs and Cosmetics (amendment) Act of 2008;

Without prejudice to any other provision contained in this Chapter, if the Central Government is satisfied that a drug is essential to meet the requirements of an emergency arising due to epidemic or natural calamities and that in the public interest, it is necessary or expedient so to do, then, that Government may, by notification in the Official Gazette, regulate or restrict the manufacture, sale or distribution of such drug.[6]

Vaccines fall under the definition of “drug” as given under the definition in section 3(b) of the Drugs and Cosmetics Act of 1940[7]. Hence, under the scope of the above statue, if the Central Government is satisfied that a particular drug or vaccine is essential to meet the requirements of the Coronavirus pandemic, it can, in public interest, regulate the manufacturing, sale and distribution of the same. 

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Generally, developing a new vaccine is an extremely expensive and complicated process. Moreover, since many candidates fail, the companies will hesitate to invest in the next phase unless the previous phase was entirely successful. But, in the instant case, financing is not an issue as the Government of India is ready to support whatever it takes. Thus, the scientists are able to perform several developmental phases at once. Given the gravity of the situation, Phase one and two of vaccine trials are being run together and if any candidate vaccine produces a very strong and potentially effective immune response, the Phase three trial might start before Phase II is complete[8].

BALANCING SAFETY AND SPEED :

Compressing the timeline has an equal chance of turning out to be either praiseworthy or a shortcoming. Clearly, if a “premium” vaccine candidate’s trails are placed on speed, a successful vaccine can reach the markets sooner. Needless to say, safety and speed has to compulsorily be balanced as the candidate vaccines are administered to Volunteers whose health cannot be compromised.

This is precisely why, institutions like Data Safety and Monitoring Boards (DSMB) exist. DSMB conducts reviews and inspections at regular intervals[9]. If the board notices that any particular candidate vaccine provides high degree protection against the virus, it will terminate the trial and advance the vaccine to approval. On the other hand, if DSMB detects signs of a vaccine causing harm, it will end the trial in order to protect the volunteers.

Vaccines are not always perfect and a perfect vaccine may not be the need of the hour. For instance, consider the small pox vaccine. It was pretty painful to receive as unlike usual vaccines, it was administered with a bifurcated needle dipped in the vaccine solution, which was pricked multiple times in the same spot causing the spot to sore and form a swab. It also gave raise to moderate-severe side effects to one out of every three who received it[10]. Yet, the vaccine was extremely successful as it wiped the entire disease off the face of Earth. The small pox vaccine may not be perfect, but it did get the job done.

SO, WHERE ARE WE NOW?

Laboratories around the world are racing to create a working vaccine for the virus that has already infected over 9.3 million people globally, and killed almost half a million[11]. Indian companies have been working on the vaccine too. Indeed, 11 out of 140 vaccine candidates are in human trials, including, two Indian vaccines, COVAXIN and ZyCov-D. The Indian ministry has recently revealed that, the manufacturers of two of the leading candidates – AZD1222 (British firm AstraZeneca) and MRNA-1273 (US-based Moderna) – have signed production agreements with Indian companies[12].

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The ICMR set August 15th, Independence Day, as the target for releasing the vaccine. Amid public eagerly anticipating the vaccine and the Department of Science and Technology’s (DST) press release, in spite of the process and approvals made flexible, it was observed that none of the vaccines was likely to be available before 2021. 


[1] Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division), Clinical Management Protocol: Covid-19, Government of India (June 27, 2020), https://www.mohfw.gov.in/pdf/ClinicalManagementProtocolforCOVID19dated27062020.pdf.

[2] Why do we need a vaccine for Covid19, COVID SYMPTOM STUDY (May 15, 2020), https://covid.joinzoe.com/post/covid-coronavirus-vaccines.

[3] The Ministry of Health and Family Welfare, National Vaccine Policy, GOVERNMENT OF INDIA (Apr 2011), https://www.nhm.gov.in/images/pdf/programmes/immunization/Guidelines/National_Vaccine_Policy.pdf

[4] Bill Gates, What do you need to know about covid19 vaccine?, GATES NOTES (Apr. 30, 2020), https://www.gatesnotes.com/Health/What-you-need-to-know-about-the-COVID-19-vaccine?WT.tsrc=BGEM

[5] John Power, How long will a coronavirus vaccine take? A Q&A with Jerome Kim, head of the International Vaccine Institute, MSN NEWS(Apr. 11, 2020), https://www.msn.com/en-sg/news/other/how-long-will-a-coronavirus-vaccine-take.

[6] Authority of Ministry of Law and Justice, Drugs and Cosmetics (Amendment) Act, 2008, GOVERNMENT OF INDIA (Dec. 5, 2008), https://www.india.gov.in/drugs-and-cosmetics-amendment-act-2008.

[7] Cf., Authority of Ministry of Law and Justice, Drugs and Cosmetics Act, 1940, GOVERNMENT OF INDIA, https://www.india.gov.in/drugs-and-cosmetics-act-1940.

[8] supra 5.

[9] Accord, Data Safety and Monitoring Boards (DSMB)Guidelines, NATIONAL INSTITUTE OF DENTAL AND CARNIOFACIAL RESEARCH (July 2018), https://www.nidcr.nih.gov/research/human-subjects-research/interventional-studies/data-and-safety-monitoring-board-guidelines

[10] supra 6.

[11] Brittney Deguara, Coronavirus: First Covid-19 vaccine might not be perfect, but it will be ‘useful’, STUFF (June 25, 2020, 10:19), https://www.stuff.co.nz/national/health/coronavirus/121930485/coronavirus-first-covid19-vaccine-might-not-be-perfect-but-it-will-be-useful.

[12] Accord, Aravind Gunasekar, India’s COVID-19 Vaccine Trial “Marks Beginning Of The End”: Centre, NDTV (July 06, 2020 08:21 am IST), https://www.ndtv.com/india-news/india-covid-19-vaccine-trial-marks-beginning-of-the-end-centre-2257525


Cite this article (The Bluebook 20th ed.)-

Nikhila S., Understanding Laws for Approval of Vaccines and Its Flexibility during Pandemics, Ex Gratia Law Journal, (October 1, 2020), https://exgratialawjournal.in/journal/volume-1-issue-2/understanding-laws-for-approval-of-vaccines-and-its-flexibility-during-pandemics-by-nikhila-s/.

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Author

Nikhila S.
Student - SASTRA Deemed to be University