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.
7 soldiers killed as army vehicle falls into river in Ladakh, Air Force taking injured to hospital
A major accident happened in Ladakh. The army vehicle slipped off the road and fell into the Shyok river. At least seven army personnel have been martyred in this accident. The rest are said to be
In 10 districts in 11 states, the speed of corona doubled within 10 days, the number of active patients increased for the third consecutive day in the country.
The number of corona patients in the country is steadily increasing. On Thursday, for the third consecutive day, an increase in active cases was recorded. Within the last 24 hours, 16 thousand 824
Know the features of the new launch phone Lava Blaze Next in 5 points, the sale of the phone started on Amazon
Recently the cheapest phone of the Lava brand has been launched Lava Blaze Next. The phone has been launched in 3 bright colors Blue, Green, and Red. If you want a cheap phone with all the smart
Bihar Board 10th Exam 2022: News of maths paper leak on the very first day of the exam, investigation continues
Bihar Board 10th Exam 2022: Bihar Board has started class X board examinations from today, February 17, 2022. This time the government has claimed a malpractice-free examination, but the news of the
Omicron Effect: Center gave strict instructions, asked states to increase tests, know what are the guidelines in 8 points
The effect of the atmosphere of concern created around the world regarding the new variant of Corona, Omicron, is also being seen in the country. On Sunday, the central government has directed the
Bharat Jodo Yatra: Kharge reached Rahul before the election of Congress President, now the crisis in front of the Gandhi family
Today is the 38th day of Congress's Bharat Jodo Yatra and it has started from Halkundi village in Karnataka. Today's padayatra is special because Congress President election candidate Mallikarjun
IPL 2021, RR vs RCB: Bangalore can give Daniel Symes a chance against Rajasthan, this could be the playing XI of both teams
The 16th match of IPL 2021 will take place between Royal Challengers Bangalore and Rajasthan Royals on Thursday. The match will be played at Wankhede Stadium in Mumbai from 7.30 pm today. Virat
Modi-Modi slogans in Owaisi's election rally: Muslim youths showed black flags to AIMIM chief, campaigning in Surat
AIMIM Chief Asaduddin Owaisi is on a tour of the state due to the Gujarat assembly elections. On Sunday, when he was addressing an election rally in Surat's Rudarpura Bay area, some Muslim youths
Congress will take out Bharat Jodo Yatra from Arunachal to Gujarat: Rahul Gandhi said - We do not have our own house for 52 years, Sonia became emotional
Congress leader Jairam Ramesh said on the third and last day of the ongoing 85th Congress session in Chhattisgarh's capital Raipur that the party is considering taking out Bharat Jodo Yatra from
Assam-Meghalaya Border Dispute: The situation tense in Meghalaya's Jaintia Hills, Assam stops fuel supply
Assam-Meghalaya Border Dispute Tension continued in Meghalaya and Assam on Thursday following the firing incident on the Assam-Meghalaya border. Only vehicles with Meghalaya registration were allowed
