Pfizer pledge for more equal access to RSV shot faces hurdles By Reuters

Written by Jennifer Rigby and Maggie Vick

LONDON (Reuters) – Pfizer Inc. (NYSE:) has vowed to deliver important new drugs more quickly in low-income countries, but the first such effort at a vaccine faces hurdles that will likely delay distribution in poor countries by several years, global health officials told Reuters.

Pfizer last year pledged fairer access, after criticism that it prioritized rich countries for COVID-19 shots early in the pandemic. The company says it wants to shorten the timeline in which poor countries get vaccines many years after they are available elsewhere.

The drugmaker received a $28 million grant from the Bill & Melinda Gates Foundation in September to support the launch of a respiratory syncytial virus (RSV) vaccine in poor countries, where respiratory syncytial virus — a common cold-like virus — is likely to be deadlier to very young people. children.

Pfizer’s maternal RSV vaccine is expected to be approved for use in pregnant women in August in the US and several months later in Europe, and the company plans to launch the product in both markets in the fall. Peak sales forecasts are more than $2 billion annually combined from the maternal vaccine and the RSV vaccine for seniors.

But the vaccine will need a different delivery system for use in developing countries in Africa and Asia, including alternative packaging and syringes. Preparations for these modifications are just beginning, according to the WHO and the company — which will likely delay delivery by several years.

Health officials say the case highlights equal global access to better advance planning by drug companies, governments and health organizations.

“They could have tried sooner,” said Irene Sparrow, WHO’s technical officer for the RSV vaccine, referring to Pfizer. “It’s a little frustrating, but now they’re doing the right thing.”

Pfizer says it is committed to a faster timetable for rolling out drugs to poorer countries, but acknowledges that there are challenges in achieving such goals.

“We are committed to working with the appropriate organisations, including regulatory authorities and other global health partners, to help ensure that the vaccine candidate, once approved, is made available in low- and middle-income countries as quickly as possible,” said a Pfizer spokesperson. When asked about the RSV filming schedule.

In an interview last month, Pfizer’s head of vaccine research and development, Annalisa Anderson, said the company still aims to make its vaccine — the first of its kind — available to pregnant women in low-income countries in roughly the same “time frame.” As is the case in rich countries.

And it pledged last May to deliver its existing portfolio, as well as newly developed drugs and vaccines, on a not-for-profit basis to 45 low-income countries in a faster timeframe than in the past.

Anderson said the company learned during the COVID-19 pandemic that “parallel development” to meet the needs of different regions was possible.

learning curve

RSV rates have skyrocketed since the pandemic. Vaccination of pregnant women against RSV can protect babies from the virus that kills nearly 100,000 children worldwide each year.

Most of these children are under five years of age, and 98% of them live in low- and middle-income countries that have fewer healthcare resources to treat the infection.

Pfizer has not yet taken a number of steps needed to make the vaccine available in developing countries, according to global health officials and the company.

They include seeking approval for the shot from the World Health Organization, whose licensing is used by governments that do not have a strong domestic drug regulator, and by nonprofit organizations — such as the global vaccine alliance Gavi — that fund purchases in low-income countries.

Early discussions with the World Health Organization are underway, but the process will be complicated because Pfizer’s RSV vaccine is not designed for syringes that automatically deactivate after a single injection, which the health agency prefers for safety reasons to prevent reuse.

In addition, the RSV injection is currently only available in a single-dose vial. In low-resource settings, multi-dose vials are often used because they are cheaper and easier to dispense.

Multiple-dose vials require the addition of a preservative, which means that the manufacturer needs to run new trials to ensure there is no effect on the safety or efficacy of the vaccine.

A source familiar with the plans said the Gates grant will be used to fund multiple-dose vial trials, which are likely to begin next year and may take another year to complete.

An official with the Gates Foundation said the investment in the RSV program represents a learning process for the foundation and the company about the steps needed to reach it more equitably.

They’ve already partnered for a maternal vaccine in early stages of development against group B streptococcus, which kills about 90,000 babies a year and causes 46,000 stillbirths, more than half of them in sub-Saharan Africa.

“We desperately want to see that time gap (between high- and low-income countries) reduce, so that there is no distance between the two,” said Padmini Srikantiah, Gates’ RSV vaccine launch lead.

She still expects it to be several years before the RSV vaccine is released in low-income countries.

“I think we’re doing a better job than in previous years,” she said. “It’s a process.”

(This story has been corrected to change the approval date in the US to August, not May, in paragraph 4)