India can ask for local trials before approving Pfizer's vaccine

Posted on 18th Dec 2020 by rohit kumar

Pfizer's Corona vaccine has so far received emergency approval in more than 5 countries, including the United States, Britain. The process of vaccinating health workers and high-groups has also started in many countries. But emergency approval will not be easy for him in India. The Subject Expert Committee of the Drug Regulator recommending emergency approval may ask him for trials in India.

 

According to a Mint report, the trial data that Pfizer has presented, it is not enough to have trial data related to Volunteers associated with Indian Ethnicity. A researcher associated with the regulatory process of the vaccine said that for any vaccine, you have to provide data on trials on the local population. If Pfizer's Global Trials had some data on the trials on the Indian population, it could have been exempted from the imperative of clinical trials. But it seems that his data is not enough. The possibility of waiver of clinical trials seems quite low at this time.

 

Earlier, Dr. Gagandeep Kang, the country's top vaccine scientist and professor of Christian Medical College, had also expressed the possibility that India's drug regulator could ask foreign vaccine for trials in India if they applied for emergency approval. May be asked to do this trial on 100 Indians. All this is decided on the data of trials conducted worldwide.

 

What is the need for local trials?

 

If the Drug Controller General of India VG Somani and the Subject Expert Committee approved the Pfizer vaccine, it would be a completely new technology here. Pfizer's vaccine is made up of messenger-RNA or mRNA technology, trials of which have not happened in India. In such a situation, giving emergency approval based on only global trial data can be risky.

Pfizer's global phase-3 clinical trial was attended by 37,000 volunteers. Of this only 4.3% of people were of Asian descent. Even though the overall efficacy of the vaccine was 95%, its success rate was 74.4% for people of Asian descent. 50% is considered as a cut-off for the corona vaccine, so 74.4% can also be considered a good figure. But it is also clear that the sample size was not enough.

 

Didn't the foreign vaccine approve before this?

 

A vaccinologist associated with the government organization says that it would be unprecedented to give Pfizer emergency approval locally without clinical trials. Until now, local clinical trials were mandatory for all vaccines made or imported in India. A big reason for this is India's diversified demography and socio-economic diversity. This has a great impact on the safety and effectiveness of the vaccine.

 

India Healthcare Analyst Nitya Balakrishnan of Sanford Brentstein said in a report that the sample size is not enough. We can understand the compulsion to consider giving exemption of clinical trials, but health volunteers have to take a careful decision before dosing. There is also not enough basis to grant trial exemption.

 

What about the rest of the vaccine?

 

Currently, along with Pfizer, Serum Institute of India (SII) and Bharat Biotech have also applied for emergency approval for their vaccines. SII has sought approval for the Covyshield vaccine developed by Oxford and AstraZeneca, with phase-3 trials currently running across the country. Similarly, phase-3 trials of the first indigenous corona vaccine-covaxin of Bharat Biotech are also being run in many hospitals in the country.

 

Pfizer vaccine will be cheaper for Indians

 

Pfizer has said that its vaccine BNT162b2 will be priced in such a way that people have to spend little or no. In this, he is also willing to work with the Government of India. In the US, the company has fixed the price of one dose of its vaccine at $ 19.5 (Rs 1,440). But in India, this rate may be reduced.

Another problem with Pfizer's vaccine is to keep it at -70 ° C, for which the company has developed special temperature-controlled thermal shippers, which can be used as a temporary storage unit. Compared to Pfizer, SII's vaccine - Covyshield is going to be around 3 dollars i.e. about 221 rupees. Similarly, the Russian vaccine Sputnik V will also be cheaper than Pfizer and one of its doses will cost 10 dollars (Rs 735). The vaccines of indigenous vaccine companies Bharat Biotech and Zydus Cadila are priced between $ 3- $ 6, ie between 220 to 500 rupees.