A group of global health organizations is calling on Gavi, the Vaccine Alliance to “immediately commence” support for the introduction of hepatitis B vaccinations at birth, which was supposed to start in 2021 but have been delayed due to the COVID-19 pandemic.
In an open letter published in The Lancet Gastroenterology and Hepatology journal on Monday ahead of a Gavi board meeting this week, the organizations, which included the World Hepatitis Alliance, PATH, and the Médecins Sans Frontières’ Access Campaign, said Gavi had “committed” to support countries to introduce the vaccine from 2021. However, they said in 2020, the Gavi board decided to defer the program and reassess it after the “acute phase” of the COVID-19 pandemic.
“It's just not really something that we can just kind of sit back and wait for.”
— Cary James, CEO, World Hepatitis AllianceMany countries have now relaxed their COVID-19 restrictions and are no longer treating the pandemic as an emergency. However, according to the letter, implementation of the program “has remained on hold.”
Hepatitis B is a life-threatening viral infection that attacks the liver, putting people at risk of dying from cirrhosis and liver cancer. World Health Organization estimates in 2019 put the number of people living with chronic hepatitis B infection at 296 million, with 1.5 million new infections per year. There were also 820,000 deaths related to hepatitis B in 2019, according to WHO estimates.
The hepatitis B burden is highest in the WHO Western Pacific and Africa regions. However, according to the open letter, fewer than one in five children in the African region receive the Hepatitis B vaccine at birth, despite WHO recommendation for it to be administered within 24 hours after birth.
Without vaccinations, 9 out of 10 infants infected with hepatitis B infection at birth are expected to progress to chronic hepatitis B infections, according to the U.S. Centers for Disease Control and Prevention.
It is estimated that 260,000 children were born or acquired hepatitis B at birth in 2021, said Cary James, chief executive officer of the World Hepatitis Alliance.
“The mortality from hepatitis B is so huge. We just feel that this needs to be prioritized and not delayed any longer,” he told Devex by phone.
But there’s concern that support for the program will be further delayed. In a call involving Gavi and several organizations last month, James said there is a recommendation to delay and again reassess Gavi support for the program in 2024.
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“So not even … commence the program, but reassess it again. And this is the other reason we really want to bring it up now. Because if they start to reassess the process again in 2024, I mean that means there’s nothing that's going to be implemented until post-2026 And … it's just not really something that we can just kind of sit back and wait for,” he said.
In an emailed response to Devex, a Gavi spokesperson said they paused the addition of certain new vaccines in Gavi’s portfolio “until the acute phase of the COVID-19 pandemic is over, to enable immunisation programmes to have adequate time to recover and rebuild.”
That pause has affected many of the vaccines included in Gavi’s 2018 vaccine investment strategy — VIS 2018 — that were supposed to be included in the organization’s portfolio from 2021, which includes not just the vaccine for hepatitis B at birth, but also vaccines for cholera, diphtheria, tetanus and pertussis-containing boosters, and rabies post-exposure prophylaxis.
Gavi, however, has “continued to prepare for a possible future programme with activities that inform a Hepatitis B birth dose programme design,” the spokesperson said. That includes a study to assess the effectiveness of timely hepatitis B birth dose vaccination in Africa. The organization is also planning a second study to assess the feasibility of providing the vaccine outside of a health facility.
“The Secretariat is developing further analyses as part of preparations for a discussion on the VIS 2018 Vaccine pause with the Policy and Programme Committee of the Gavi Board in mid-2023,” according to the spokesperson.
Update, Dec. 6, 2022: This article has been updated to clarify that the open letter was published in The Lancet Gastroenterology and Hepatology journal.