The Pfizer-BioNTech COVID-19 vaccine might soon make its way to India. The company is currently in talks with the Indian government to get emergency use approvals for its vaccine. The firm has also announced it will donate medicines worth $70 million (over ₹510 crore) for the treatment of COVID-19 patients in India. The vaccine has been approved in the Middle East, US, UK, Canada, some South American countries, as well as in most of European countries.
People aged 18 and above can take the Pfizer-BioNTech vaccine. However, the company is also vying for approvals to roll out this vaccine for adolescents. It has 91.3 percent efficacy in fighting off COVID-19, and a recent study in Israel has shown two doses offered 95.3 percent protection against infection and 96.7 percent protection against death seven days after the second dose.
Vaccines
India recently changed its rules for bridge trials of COVID-19 vaccines. Previously, a vaccine had to undergo a clinical trial in India, proving its efficacy, before it was given approvals. Now a vaccine will be approved if it has already been approved by the US Food and Drug Administration (USFDA), European Medicines Agency (EMA), UK Medicines and Healthcare Products Regulatory Agency (UK MHRA), Pharmaceuticals and Medical Device Agency (PMDA) Japan, or those listed by the WHO (emergency use listing). That said, it will have to undergo a clinical trial within 30 days of receiving emergency use authorisation.
Pfizer had applied for emergency use approvals in India earlier, but withdrew its application in February due to the abovementioned rule. In April, the US pharma company offered its vaccine at a not-for-profit price for the Indian government's immunisation programme, PTI reported. It communicated to the Indian government that there is no concern over the safety of its vaccine, and that it was working on a way to get the required approvals to make the vaccine available in the country.
A Pfizer spokesperson told Reuters that the safety and efficacy data had been backed by regulatory authorities in the United States, Britain, Japan and the WHO, all agencies that India endorses.
Today we have announced we are mobilizing the largest humanitarian relief effort in our company’s history to help the people of India fight the vicious second wave of coronavirus that is currently ravaging the nation. pic.twitter.com/klVnkAjkcw
— Pfizer Inc. (@pfizer) May 3, 2021
In a video statement, Pfizer CEO Albert Bourla said access to vaccines is critical to ending this pandemic. “Unfortunately, our vaccine is not registered in India, though our application was submitted months ago. We are discussing with the Indian government an expedited approval pathway to make our Pfizer-BioNTech vaccine available for use in the country", said Bourla.
“As we work to meet the public health need and to be a partner with the Government of India to establish a path forward for our vaccine, please know you and your loved ones are foremost in our thoughts and prayers," he added.
In a Reuters report, Pfizer, along with its German partner BioNTech SE, said it would supply its vaccine doses only through government contracts.
Also read: US to approve Pfizer-BioNTech COVID-19 vaccine for kids aged 12 and above by next week
Humanitarian aid
In an e-mail sent to Pfizer's Indian employees shared on LinkedIn, Bourla said the company is donating $70 million (over ₹510 crore) worth of medicines to fight COVID-19 in India. He also said this is the company's "most comprehensive humanitarian relief response ever."
He said, “Right now, Pfizer colleagues at distribution centres in the US, Europe and Asia are hard at work rushing shipments of Pfizer medicines that the Government of India has identified as part of its COVID treatment protocol.”
“These medicines, valued at more than $70 million, will be made available immediately, and we will work closely with the government and our NGO partners to get them to where they are needed most,” Bourla added. He said, they will be given to public hospitals and will be given free of charge, to ensure people who need them have access to medicines.
We are donating enough of these medicines to ensure that every COVID-19 patient in every public hospital across India can have access to them in the next 90 days free of charge. This effort has the potential to impact the lives of hundreds of thousands of patients. pic.twitter.com/9YEv3IQ3zo
— Pfizer Inc. (@pfizer) May 3, 2021
Bourla said, "This effort, in combination with the Pfizer Foundation funding that supports humanitarian organisations providing essential and life-saving equipment to India, such as ventilators, oxygen concentrators and consumables, is our most comprehensive humanitarian relief response ever."
Is Pfizer a viable option?
One of the main reasons the vaccine hasn't made its way to India and other Asian countries as yet is because it is not ideal for tropical climates. Because of the genetic material it’s made from, the vaccine needs to be stored at temperatures of -70 degrees Celsius or lower. There is a dearth of ultracold refrigerators in India, which means storage is an issue. According to a Reuters report, in Asia, Africa and Latin America, the heat, along with poor infrastructure and logistical hurdles in rural areas and islands pose a challenge for this vaccine.
However, a statement from Pfizer's CEO reveals the firm may have a solution to this problem.
Pfizer said it has designed special "temperature-controlled shipping containers" that can maintain the required temperature for up to 10 days if not opened. He also said once opened, these containers can be used as "temporary deep freezers" for up to 30 days if they are re-iced every five days. The vials of the vaccine themselves can be "stored at refrigerator temperatures (two to eight degrees Celsius} for five days once they are taken out of the freezers.
For the sake of easing transportation, Pfizer said these containers are the size of a carry-on suitcase, which means they are compact and small enough to be moved around easily and efficiently. Each of these containers has "temperature-enabled GPS trackers" that will allow the pharma company to track the location and monitor the temperature to ensure the vials are ready for use when they reach their destination.
With inputs from wires
Also read: Pfizer/BioNTech seeks EU's approval to vaccinate children between ages 12-15 years
source https://www.firstpost.com/health/pfizer-biontech-covid-19-vaccine-may-come-to-india-emergency-approval-on-the-cards-9597411.html
