The WHO in its latest Strategic Advisory Group of Experts on Immunization (SAGE) has revised the roadmap for prioritising use of COVID-19 vaccines. Here’s all you need to know
The multi-year collaboration is focused on cancer immunotherapies based on mRNA or other drug classes, infectious disease vaccines, and investments into expanding the company's footprint in the UK, BioNTech said in a statement on Thursday.
African countries struggled early in the pandemic to secure COVID vaccines as rich countries hoarded doses. But many are now well-supplied with shots and are instead having trouble administering them, either because of hesitancy or logistics.
Moderna Inc. said it’s suing Pfizer Inc. and BioNTech SE, claiming the technology in the partners’ Covid-19 shot infringes on its patents, a move that sets the stage for a massive legal clash between the three vaccine titans.
The companies said the vaccine was safe and well-tolerated by the children, and they plan to soon ask global regulators to authorize the shot for the age group, children for whom no vaccine is currently approved in most of the world.
Blood serum analysis of a few pediatric participants who received a booster dose in the study showed a 36-fold increase in Omicron neutralizing antibodies, the drugmakers said.
Mainz-based BioNTech said it made a net profit of 10.3 billion euros ($11.5 billion) last year, up from 15 million euros in 2020, the first year of the pandemic.
BioNTech had previously expected to launch the vaccine by end of March, but said in late January that this depended on how much clinical data regulators would require.
U.S. regulators are considering the first COVID-19 vaccine for children under the age of 5, the only age group not yet eligible for the shots, after Pfizer Inc and BioNTech SE began the regulatory approval process on Tuesday.
The older teens, 16- and 17-year-olds, became eligible for boosters in early December.
In the first official statement from vaccine manufacturers on the likely efficacy of their shot against Omicron, BioNTech and Pfizer said that two vaccine doses resulted in significantly lower neutralising antibodies but that a third dose of their vaccine increased the neutralising antibodies by a factor of 25.
The companies have sold the vast majority of their doses to rich countries, leaving low-income nations in the lurch, said the People's Vaccine Alliance (PVA), a coalition campaigning for wider access to COVID vaccines, which based its calculations on the firms' own earning reports.
An authorization for that age group would be would be an important regulatory step toward reaching about 28 million children for inoculation, most of them back in school for in-person learning.
The advisers are expected to pay close attention to the rate of rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.
The data, which was published in the Lancet published medical journal, had been previously released in August ahead of peer review.
Rare cases of myocarditis, an inflammation of the heart muscle, have been reported in people who have taken the Pfizer vaccine, especially in young men.
Children have been infected in greater numbers in the latest wave driven by the Delta variant, and inoculating this age group is seen as key to keeping schools open and helping end the pandemic.
Pfizer and BioNTech presented the results of their Phase One trial that evaluated the safety and efficacy of a third shot.
The supply tally, up from more than 700 million doses announced by the biotech firm in June, compares with AstraZeneca saying late last month that it and manufacturing partner Serum Institute of India had supplied a billion doses to 170 countries at the time.
Pfizer and BioNTech initiated a Phase 2/3 study in June 2021 to further evaluate the safety, tolerability and immunogenicity of BNT162b2 vaccine in preventing COVID-19 in healthy children aged 6 months to 11 years.
The monoclonal antibody is used for treatment of COVID-19 in India and some other countries.
Taiwan had tried for months to get the vaccine from the German company, until on Sunday BioNTech's Chinese sales agent, which also has the right to sell the shot to the island, said it would sell 10 million doses to two Taiwanese tech giants, after Taiwan's government said they could negotiate on their behalf.
The Pfizer-BioNTech vaccine was granted emergency clearance for use on all adults in the United Kingdom in December last year.
Immunizing children against COVID-19 might also give authorities more confidence to reopen schools, as getting children to wear masks and engage in social distancing has been challenging at times.
The US FDA said it had made the decision "based on a review of recent data submitted by Pfizer"