- Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
- Experts say Pfizer’s vaccine ‘promising’ but highlight cold storage issues
- Pfizer in talks with central government for the vaccine: Spokesperson
New Delhi: “Today is a great day for science and humanity,” said Dr. Albert Bourla, Chairman and CEO of the USA based pharmaceutical company Pfizer while announcing the first set of results from the Phase 3 trial of the COVID-19 vaccine candidate, BNT162b2, developed by the firm in partnership with the biotech firm BioNTech. As per the preliminary analysis, Pfizer’s vaccine candidate can prevent more than 90 per cent of people from getting COVID-19. According to the World Health Organisation (WHO), this is a great achievement in the fight against the pandemic as the standard of efficacy that it recommends is about 50 per cent. As various countries around the world celebrate the milestone and secure the required doses from Pfizer, NDTV tried to find out if India will also benefit from it.
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Pfizer claims that their vaccine has been tested on 43,500 people in six countries- USA, Germany, Brazil, Argentina, South Africa, and Turkey and no safety concerns have been raised during trial studies. Pfizer Spokesperson said to NDTV that the 90 per cent efficacy result is based on the findings of the phase 3 evaluation of 94 confirmed COVID-19 patients and plan to evaluate at least 164 patients. She said,
Pfizer and BioNTech have announced that its vaccine candidate was found to be more than 90 per cent effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection. It is based on the first and only interim efficacy analysis conducted by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study. This first interim analysis evaluated 94 confirmed cases of COVID-19 in participants without prior SARS-CoV-2 infection 16 to 85 years of age. As established in the protocol, we will continue the study until we accrue at least 164 cases and conduct the final analysis.
UPDATE: We are proud to announce, along with @BioNTech_Group, that our mRNA-based #vaccine candidate has, at an interim analysis, demonstrated initial evidence of efficacy against #COVID19 in participants without prior evidence of SARS-CoV-2 infection.
— Pfizer Inc. (@pfizer) November 9, 2020
Pfizer believes it will be able to supply 50 million doses by the end of this year, and around 1.3 billion by the end of 2021. It plans to apply for emergency approval to use the vaccine by the end of November. The Pfizer Spokesperson said,
If our vaccine candidate is successful, we would allocate the available 2020 doses proportionally across the countries where we have fully executed supply agreements that include delivery of a portion of doses in 2020.
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Will The Pfizer-BioNTech Vaccine Become Available In India Any Time Soon?
The Pfizer Spokesperson said that the company is keen on marketing the vaccine in the country and is in discussion with the government regarding this. She said that Pfizer’s vaccine has the potential to be an important part of the country’s early vaccine response to the pandemic in priority regions and populations. She added,
Pfizer is committed to ensure the availability of this vaccine for use by governments across the world. We seek to work with governments to support distribution to their defined priority groups. We remain committed to engaging with the Government of India to advance our dialogue and explore opportunities to make this vaccine available for use in the country.
An official from the Ministry of Health and Family Welfare, Government of India, has confirmed that the country is in talks with Pfizer for its COVID-19 vaccines along with some other domestic and foreign developers and manufacturers of vaccines candidates that are ahead in the race.
However, as of today, a major roadblock that experts have identified in administering Pfizer’s vaccine in India is that of storing and transporting the vaccine. This is because the vaccine is based on a technology that uses synthetic mRNA (Messenger ribonucleic acid) to activate the immune system against the coronavirus, comes with special challenges as it needs to be stored at extremely cold temperature. Pfizer says that the BNT162b2 vaccine would need ultra-cold chain – storage at minus 75 degrees Celcius before being distributed. But the country does not have such a cold chain facility that can provide such low temperatures. Pfizer Spokesperson said,
Most vaccines need cold chain storage and we have developed detailed logistical plans and tools to support effective vaccine transport, storage and continuous temperature monitoring. Initially, our potential COVID-19 vaccine will need to be stored at -75°C±15°C. We have experience working with customers in all markets and have developed comprehensive solutions to partner with countries to help in the deployment of this vaccine. We also believe that with the scale required in India, it can be expected that there may eventually be multiple vaccines deployed in the country.
Dr. K K Aggarwal, President, Confederation Of Medical Associations In Asia And Oceania, said that the 90 per cent efficacy results of the vaccine is encouraging news but highlighted that maintaining a cold chain with temperature this low is a challenge for developing countries like India, especially in the rural areas.
While talking about how a cold chain for vaccines works, Dr. Aggarwal explained,
After getting manufactured, the vaccines are sent to the destination country via air packed in refrigerated boxes. From the point of arrival, the vaccines are carried in the refrigerated vehicle to cold room. These are then distributed in portable iceboxes to the regional centre where the vaccines are stored in electric refrigerators at the desired temperature. The vaccine doses are then carried in portable iceboxes to local venues for vaccine campaigns.
Dr. Aggarwal said that even if the country is able to develop a cold chain for Pfizer’s vaccine, it will not be able to do IT on a mass scale immediately and will not be able to make it to the immunisation mission of the nation. Therefore, making the vaccine expensive and limited to the affluent population of the country who can afford it.
By the time we create a cold chain for Pfizer’s vaccine, we will have more vaccines ready for registration. There is no need to be worried if this particular vaccine is not practical for India.
He added that even though the announcement made by the company is a very promising sign for vaccine development, there is still a need to see how long the response would be because the longer the antibody response, the longer would be the protection against the COVID-19. He said that even though the vaccines are being developed fast, the best way of getting out of the pandemic is to continue practising preventive measures that include frequent handwashing, social distancing and wearing a mask along with strengthening the public healthcare system and devising better treatments.
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NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the currentCOVID-19 pandemic, the need for WASH (Water,SanitationandHygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fightmalnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India wheretoiletsare used andopen defecation free (ODF)status achieved as part of the Swachh Bharat Abhiyan launched byPrime Minister Narendra Modiin 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues likeair pollution,waste management,plastic ban,manual scavengingand sanitation workers andmenstrual hygiene.