Covid-19 roundup: CureVac vaccine now not expected before August — report; A Covid-19 vaccine trial in Africa is ready to test patients with HIV, but there aren't any vaccines available for it
The clock has been ticking for German drugmaker CureVac and its push toward a Covid-19 vaccine. Time might be running out, as a source from the EMA told Reuters that the agency does not expect CureVac to make a decision on the jab’s approval before August.
German health minister Jens Spahn gave an update on the timetable in a Monday call, the story reports.
Previously, the company’s co-founder and chief production officer Florian von der Mülbe blamed delays, at least in part, on supply chain issues caused first by US delays. Vaccine makers looking to house production in Europe are at a disadvantage because suppliers in the US are required to cater to the home market at first under the Defense Production Act, he said.
In July 2020, GSK pumped $293 million into CureVac’s mRNA-based vaccine, in a deal that left CureVac in charge of all of its manufacturing. The company has made efforts to stay ahead of variants as they’ve popped up.
The EU has secured up to 405 million doses of the vaccine so far, and Germany has signed a memorandum for another 20 million. But those are the only 2 deals that CureVac has landed, as now it’s forced to be realistic on the amount of time it will take to produce the vaccine.
While demand for Moderna and Pfizer/BioNTech’s vaccines — which both are mRNA-based — has grown recently, CureVac’s vaccine could thrive in lower-income countries that don’t have as much access to these jabs.
A Covid-19 vaccine trial in Africa is ready to test patients with HIV, but there aren’t any vaccines available for it
Health officials in Africa have voiced a growing concern that a third wave of Covid-19 infections is coming as case numbers have steadily increased in South Africa since April 28. But while there’s a trial all ready to go to test the efficacy of mRNA vaccines against one of the key variants, as well as pregnant patients and those with HIV, the continent has struggled to secure enough shots for it.
Science Magazine reported Monday that Pfizer and Moderna have yet to provide any vaccines for the trial, even though it is ready to launch in 8 sub-Saharan countries.
The NIAID has agreed to pay for the study, and a group of HIV advocates and South African activists have penned a letter to director Anthony Fauci complaining about the delay. HIV patients can be hit by Covid-19 particularly hard, they say, because the virus lowers immune response.
“We believe this will be a landmark study for this region and … the world,” the letter said. “We respectfully ask that you do all in your power to enable this study to take place.”
The trial is aimed at testing the protection of the vaccines against the South African variant, now dubbed Beta. Non-mRNA vaccines — including those from Novavax and J&J — don’t seem to offer enough protection in people with HIV, Science reports. Pfizer’s vaccine has demonstrated 100% efficacy against the South African variant, while J&J’s just showed 57% and AstraZeneca’s 11%.
The trial involves 14,000 patients in South Africa, Botswana, Zimbabwe, Eswatini, Malawi, Zambia, Uganda and Kenya, where HIV prevalence is as high as 27%. Half the participants were set to receive the Moderna vaccine, while the other half would receive a placebo. But Moderna pulled out, citing liability concerns and troubles with the study’s design, according to Science.
A hesitancy to provide the vaccine for the trial could be a step back for the Cambridge, MA drugmaker, just as it’s been running full speed ahead in the last 2 months or so. After a delay in announcing just how many doses the company would provide to COVAX, in an agreement with Gavi, the vaccine alliance, for distribution in lower and middle-income countries, Moderna pledged 500 million doses of the vaccine to the program by the end of 2022 in early May. Along with that announcement came the news that manufacturing would be kicked into high gear, as the company pledged to make doses in Korea, Switzerland and even Australia.
“We said, ‘What can we do for the world?’ and we basically went back to our board and said, “We need to do massive investment,” CEO Stéphane Bancel told Endpoints News at the end of April. “We need to aim to increase our capacity for next year so that we can make sure we can vaccinate and boost everybody.”
In theory, the US government could still provide Africa with the doses it needs for the trial to take place. However, the Public Readiness and Emergency Preparedness Act that indemnifies manufacturers only stands in the US, leaving a slight window for a lawsuit against Moderna, should something go wrong.
Children as young as 6 months old to be included in Pfizer vaccine study
Pfizer’s vaccine has been approved for children above the age of 12, but Tuesday, the company announced it will start studying the vaccine in children ages 12 and under, Reuters reports.
Pfizer has remained a step ahead of the competition when it comes to gaining approval for vaccine use in kids. The announcement follows the approval of Moderna’s vaccine in use for children in both Canada and the EU on Monday.
Children between the ages of 5 and 11 will get a dose of 10 micrograms, while anyone younger will get a dose of 3 micrograms.
The study will enroll up to 4,500 children in the US, Finland, Poland and Spain, the company said.
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