Tuesday, March 2, 2021
Home News Reports Pfizer Inc withdraws application for emergency use authorisation of its Covid-19 vaccine in India

Pfizer Inc withdraws application for emergency use authorisation of its Covid-19 vaccine in India

Pfizer said that the regulators in India needed more information regarding the vaccine, owing to which it was withdrawing the application for emergency use of the Pfizer vaccine.

Pfizer Inc, which has developed a COVID-19 vaccine in collaboration with Germany’s BioNTech, has reportedly withdrawn the application for emergency use of its vaccine in India. The US company, which was the first company to apply for emergency use authorization of its COVID-19 vaccine in the country, took the decision after it participated in the Subject Expert Committee meeting of the Drug Regulatory Authority of India on February 3.

Following the meeting, the company issued a statement in which it said that the regulators in India needed more information regarding the vaccine, owing to which it was withdrawing the application for emergency use of the Pfizer vaccine in India. “Based on the deliberations at the meeting and our understanding of additional information that the regulator may need, the company has decided to withdraw its application at this time”.

It added that it will in the future look to resubmit its application with the additional information that the regulator requires. “Pfizer will continue to engage with the authority and re-submit its approval request with additional information as it becomes available in the near future.”

The US-based company had sought authorisation for the emergency use of its vaccine in India late last year. However, the Drug Regulatory Authority of India gave its approval to two much economical vaccines- the vaccine developed by Oxford University/AstraZeneca and another made in India vaccine developed by Bharat Biotech together with the Indian Council of Medical Research. 

India’s Central Drugs Standard Control Organisation had declined to accept Pfizer’s request for approval unless it participated in a small local trial to determine the vaccine’s safety and immunogenicity for Indians. Indian health officials opined that since the genetic constitution of an Indian can be different from people in Western nations, this is a pre-requisite. The developer has to agree for the local trial to determine if a vaccine is safe and generates an immune response in its citizens.

Serious allergic reaction like Anaphylaxis reported after administration of Pfizer vaccine

The US-based pharma giant Pfizer and its German partner BioNTech had during initial trials of its vaccine had said that they had not found any serious safety concerns and claimed that the vaccine is more than 90% effective. Britain had become the first Western country to authorise the emergency use of a coronavirus vaccine developed by Pfizer and BioNTech. However, following the implementation of the first dose of the vaccination, reports of serious allergic reaction like Anaphylaxis emerged. Anaphylaxis is a life-threatening allergic reaction that occurs rarely after vaccination.

Logistics is another major concern for the US-based vaccine

Besides this, another major issue pertaining to the Pfizer vaccines is its logistics, since the vaccine requires to be stored in minus 70 degrees (-94 F) or below. Amesh Adalja, the senior scholar at Johns Hopkins Center for Health Security, said, “The cold chain is going to be one of the most challenging aspects of the delivery of this vaccination.” Even in the big cities, the hospitals do not have such storage facilities where storing vaccines at ultra-low temperature is possible.

In general, the refrigeration system at most of the storage facilities across the globe store medicines at 2-5 degrees above the freezing point. In such a situation, the Pfizer vaccine will be viable only for five days after which it will spoil. Owing to this, the distribution of the vaccination in the developing countries and rural areas pose as a major challenge.

As compared to the US based vaccine, vaccine of Moderna Inc which works on similar technology as Pfizer, need not be stored at such low-temperature. Vaccines by Johnson & Johnson and Novavax Inc too can be stored at 2-8 degrees, which is in the normal range of storage facilities’ refrigeration units.

  Support Us  

Whether NDTV or 'The Wire', they never have to worry about funds. In name of saving democracy, they get money from various sources. We need your support to fight them. Please contribute whatever you can afford

OpIndia Staffhttps://www.opindia.com
Staff reporter at OpIndia

Related Articles

Trending now

Dr B R Ambedkar’s grandson claims PM Modi took vaccination from Christian nurse as he does not ‘believe in Hindu nurses’

Prime Minister Modi on Monday took the first dose of coronavirus vaccine in Delhi's AIIMS. He was administered the dose of made-in-India Bharat Biotech's COVAXIN.

Rahul Gandhi has made his choice: He prefers street power to political power

Congress, the Left and ISF have now formed a 'secular' alliance to fight the Bengal polls and are in the process of finalising their seat-sharing formula

A woman molested, a father murdered, a Samajwadi Party leader accused: Here is all you need to know about the Hathras case

"Aatankwadi hain woh", Hathras victim Pooja exclaimed, expressing her angst against the SP leader for killing her father

Ajay Maken becomes one of the first party leaders to take COVID-19 jab even as Congress maintains silence over vaccination drive

Congress leader Ajay Maken, along with his wife, mother and mother-in-law took the first dose of COVID-19 vaccine this morning at Guru Gobind Singh Hospital in Delhi

FIR against Aam Aadmi Party MLA Abdul Rehman for molestation, assault, was earlier booked for anti-CAA violence

Abdul Rehman, who is a legislator from the Seelampur constituency, claimed that the allegations against him are 'false' and 'baseless'.

Dissenting Congress leaders plan to hold another event in Haryana, question party’s election strategy in West Bengal

Hitting out at the Congress, G-23 leader Anand Sharma questioned the decision of the party to forge an alliance with radical cleric Abbas Siddiqui's Indian Secular Front (ISF).

Recently Popular

‘Inserted her hand claiming she was planting a tree’: LGBT activist Divya Dureja accused of sexual assault under pretext of shamanic ritual

A popular LGBT activist Divya Dureja has been accused of sexual assault by Elodie Gendron under pretext of a Shamanic ritual.

The Hindu ‘journalist’ Suhasini Haidar puts out misinformation about ISRO satellite launch: Read details

Suhasini Haidar, National Editor of 'The Hindu', put out false information on social media in attempt to mislead the public.

Gujarat: Ahmedabad woman Ayesha commits suicide by jumping into Sabarmati River, last video message goes viral

A video has gone viral on social media where Ayesha, a young woman, can be heard announcing her decision to commit suicide.

US President Joe Biden casually drops the N-word during Munich Security Conference, accused of racism on social media

The N-word is considered as one of the hateful words that were first uttered in the 17th century. Its origin can be traced back to the Spanish word 'negro', which is often used by white supremacists to deliberately offend the African-American community.

Rashmi Samant, president-elect of Oxford Student Union resigns after online attacks over her Hindu roots and old social media posts

An Oxford University staff member dragged Rashmi's parents in the controversy, using their display picture which had Lord Ram's photo.

Australian media slam Justin Trudeau for abstaining vote against China, calls his government the most pathetic in the history of the Five Eyes

Sky News Australia host called Justin Trudeau government the most pathetic in the history of Five Eyes nations
- Advertisement -

 

Connect with us

253,147FansLike
521,301FollowersFollow
23,800SubscribersSubscribe