The US government is buying an additional 200m doses of the BioNTech/Pfizer Covid-19 vaccine, expanding its total order to 500m, as officials prepare for the next phase of vaccinations, including children under 12 and potential booster shots.
Doses of the messenger RNA shots — to be delivered between October and April next year — will either be the current formulation or one that has been adapted to coronavirus variants. The companies are testing whether a shot tailored to the Delta variant is more effective in studies set to begin next month.
A Biden administration official familiar with the contract said the government was exercising an option to buy the 200m doses “to prepare for future vaccination needs, including vaccines for children under 12 and possible booster shots if studies show they are necessary”.
“Importantly, as part of the agreement, Pfizer will provide the US with 65m paediatric doses should Pfizer’s vaccine be approved for kids under 12, including doses available immediately upon authorisation,” the Biden administration official told the Financial Times.
Albert Bourla, Pfizer’s chief executive, said on Friday that the additional purchase would enable “broad access” to vaccines in the US.
“As a long-term partner to the US government in the fight against this pandemic, we are proud of the impact of vaccination efforts across the country. Vaccines have been and will remain critical to protecting lives against this devastating disease,” he said.
Pfizer has assessed that people who have already received the full two-jab regimen will probably need a third shot, even though US public health officials have been reluctant to commit to a booster programme.
The UK is preparing for a booster programme for the most vulnerable, while its scientists examine emerging evidence. The EU has also made a big bet on continuing to use the Pfizer vaccine, with an order of up to 1.8bn to be delivered by 2023.
The companies are planning to apply for US emergency use authorisation for their shot to be used as a third dose. Analysts predict a booster shot market could be worth tens of billions of dollars.
About 60 per cent of US adults are fully vaccinated, and while shots are widely available, officials have struggled to overcome high levels of vaccine hesitancy.
Covid-19 cases in the US had been in sharp decline since the country began a mass vaccination campaign in the spring. However, infections have begun to rise again in recent week, especially among the unvaccinated, as the contagious Delta variant sweeps across the country.
“I think they’re having a very hard time modelling this and they don’t know where we are in this wave of infection,” Scott Gottleib, former head of the Food and Drug Administration, told CNBC.
“I think we’re vastly under-measuring how much infection is already under way in the US, and where we are in this epidemic wave. I think we’re probably further into it than we’re measuring right now.”
Gottleib noted the CDC estimates of how many new Delta-related cases were diagnosed in the US varied widely, suggesting the agency is struggling to get a firm view on how broad the new outbreak is and how protected fully-vaccinated Americans are.
“I think we’re also having a hard time measuring what the components of immunity are and the durability of immunity,” he added.
Separately, the US government has already ordered 500m Pfizer doses at non-profit prices to provide to the developing world in 2022 and 2023, via the World Health Organization’s Covax initiative.
“It has been our consistent goal to supply as many doses of our Covid-19 vaccine as possible to people around the world to help bring an end to this pandemic,” said Ugur Sahin, chief executive of BioNTech.
But Dr Carrie Teicher, director of programmes at Médecins Sans Frontières in the US, said officials should be “moving mountains” to ensure available doses go to protect healthcare workers and the vulnerable in low and middle income countries, not investing in booster programmes prematurely.
“Leaders of governments like the US, which has already vaccinated well beyond the most vulnerable people, need to stop and take a look at this dramatic global imbalance in access to vaccines before offering boosters to vaccinated people,” she said.
Pfizer and BioNTech were the first to win approval for their Covid vaccine in many countries including the US and the UK, and more recently, the first to gain authorisation for use in teenagers.
They have capitalised on their early success and high efficacy rate by rapidly expanding manufacturing facilities to enable them to sign large contracts for the years ahead.
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