Pfizer's COVID-19 vaccine: No trials, no supply commitment major drawback

Indian arm of the US pharmaceutical firm Pfizer has submitted an application with the Drug Controller General of India (DCGI) seeking emergency use authorisation (EUA) for its COVID-19 vaccine, but Indians will have to wait a while to get the vaccine. The vaccine has already been launched in the UK.

Though Pfizer India says it remains committed to advance dialogue with Indian government to make the vaccine available for use, experts believe it will be difficult for its parent to supply adequate quantities of the vaccine in India's plan of vaccinating over 30 crore people by July. Pfizer has so far neither committed supplies to India nor initiated trials, but has sought an EUA from the government. Meanwhile, the government is looking at about eight vaccines under development to ensure it has adequate vaccines for Indians.  

Also read: COVID-19 vaccine: 30 crore Indians to be vaccinated on priority

While the UK and Canada have approved the Pfizer vaccine, an external expert committee today will review data and vote on recommending the US Food and Drug Administration (USFDA) to allow the vaccine. Similarly, regulatory processes by various nations are moving at an unprecedented pace, but the primary issue will be availability of enough doses for supply across the world, note industry observers.

 "Right now, we're in a situation where a lion's share of the limited number of first doses have already been snatched up by a handful of countries like the US and UK, as well as the EU, leaving very little for other countries in the short term. What we really want to see is a rapid expansion of the overall global supply, so there are more vaccines to go around and doses can be allocated according to WHO's public health criteria, not a country's ability to pay," says Medecins Sans Frontieres (Doctors Without Borders - MSF), a global healthcare NGO. They say companies like Pfizer-BioNTech and Moderna should share all the necessary intellectual property (IP), technologies, data and know-how, so that as many companies as possible can produce these lifesaving vaccines.

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They note that so far Pfizer and its German partner BioNTech have not licensed the technology to any other company, as done by the Astra Zeneca-Oxford  University combine. According to Pfizer, based on current projections, Pfizer's and BioNTech's combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorisation).

Of this, they have a commitment to supply 40 million doses alone to the UK with delivery in 2020 and 2021. Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech is able to produce mRNA for commercial supply after having already produced the vaccine candidate doses for the clinical trials.

BioNTech will also increase its manufacturing capacity in 2021, once a third site in Germany will start manufacturing to provide further capacities for a global supply of the vaccine. Critical to distribution in the UK will be Pfizer's manufacturing site in Puurs, Belgium, one of Pfizer's largest sterile injectable sites. The Puurs site is being used primarily for European supply but will also serve as back up supply to Kalamazoo, Michigan, for the US market, says Pfizer.

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US President-elect Joe Biden has already said he plans to distribute at least 100 million COVID vaccine shots within his first 100 days in office. US primarily expects the vaccines from Pfizer, Astra Zeneca and Moderna. Pfizer has informed the Trump administration that it was not in a position to supply substantial additional doses until late June or July. Under Operation Warp Speed of the US Government to fast track development of vaccines, Pfizer has a commitment to supply 100 million doses to vaccinate 5 crore Americans.

Though Pfizer was then ready to commit more, the US government had ordered only 100 million. The Pfizer-BioNTech COVID-19 vaccine (also referred to as BNT162b2) is administered intramuscularly as a 2-dose series spaced 21 days apart at a dose of 30 ug each. The vaccine is stored at -60 degree C to -80 degree C.

While the US missed out to secure more Pfizer-BioNTech vaccines, other developed countries had jumped in to pre-book the initial capacity till 2021. Canada's regulator Health Canada has given EUA and is expected to receive 2,49,000 doses of the vaccine before the end of this month. Canada has booked 20 million doses, with an option to buy another 76 million doses. In July, the Japanese government booked 120 million doses of the Pfizer vaccine, to be delivered in the first six months of 2021.

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Now Pfizer is doing a small-scale trial in Japan, (which it has not done so far in India). Sources say Pfizer also has a commitment to supply 200 million doses, with an additional optional 100 million to the European Union. The EU regulators are expected to clear the vaccine this month. Israel is another country that has booked the vaccine in the first slot. Other countries like Australia, New Zealand, Peru, Costa Rica, Ecuador, Kuwait, Lebanon have also pre-booked the Pfizer vaccine, leaving little for rest of the world.  

Noting that Moderna has been the only company to commit to not enforce its patents during the pandemic, MSF says Pfizer-BioNTech have indicated no plans to license or transfer their IP-protected technologies. "To increase global manufacturing capacity and supply, Pfizer-BioNTech should pursue global open-licensing and engage in full technology transfers to other vaccine manufacturers," says MSF.

Also read: Coronavirus vaccine: Govt seeks more data from Serum Institute, Bharat Biotech for emergency use authorisation