Keeping tabs on pharma: Covid-19 vaccine trials for children aged five to 11 proving effective and Oxford malaria vaccine commended for WHO-breakthrough

As the focus on vaccine development remains front-and-center in the race to curb the spread of coronavirus, this week Pharma IQ dives into some of the major vaccine clinical trials that are underway to protect children from Covid-19 and vulnerable populations from malaria

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Children under 12 next in line for Pfizer’s Covid-19 vaccine

In late March, Pfizer and BioNTech began clinical trial testing of their Covid-19 vaccine in children aged five to 11. The companies also has plans to initiate testing of their vaccine in children aged two to five and six months to two years.

The development comes as the US Food and Drug Administration (FDA) authorized Pfizer's Covid-19 vaccine for emergency use in younger teenagers aged 12 to 15, following news that its Covid-19 vaccine is 100 per cent effective in children of this age group.

Janet Woodcock, acting commissioner of the FDA, said: “The action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our Covid-19 vaccine emergency use authorizations.”

Dr. Ozlem Tureci, Co-founder and Chief Medical Officer of BioNTech, commented if clinical trials for children aged five to 11 went well and the FDA approved it, he would expect that young children could be vaccinated as early as the end of summer or fall 2021. 

Angelica LaCour, parent to Eloise LaCour, a five-year-old child participating in Pfizer and BioNTech’s clinical trial, said to NPR: “I think it is just really important to highlight that we are not going to get to herd immunity [in the US] if children are not vaccinated. We do not know the long-term impacts of the virus and we know that it is a well-tolerated vaccine that is saving people's lives. It is important that our children get that as well.”

The Pfizer-BioNTech Covid-19 vaccine, BNT162b2, has not yet been approved or licensed by the FDA for individuals that are 12 and under, but has been authorized for emergency use in a clinical trial setting by the FDA under an Emergency Use Authorization to prevent Covid-19.

After WHO-specified 75 per cent efficacy of Oxford Malaria vaccine, a “malaria-free future” looks possible

Every year, malaria claims the lives of more than 400,000 people, with more than 90 per cent of those victims residing in Africa, and 67 per cent of casualties aged five and under, according to the World Health Organization (WHO).

Despite a number of vaccines being trialed over the years, the University of Oxford has been the first to demonstrate a high-level efficacy of 77 per cent for its malaria vaccine candidate, R21/Matrix-M, in Burkina Faso. The most effective malaria vaccine to date had only shown 55 per cent efficacy in trials on African children. 

In its research findings it noted it was the first research group to meet WHO’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75 per cent efficacy.

Halidou Tinto, Professor in Parasitology and the Principal Trial Investigator at the Clinical Research Unit of Nanoro, Burkina Faso, said: “The results are very exciting, showing unprecedented efficacy levels from a vaccine that has been well tolerated in our trial program. We look forward to the upcoming phase 3 trial to demonstrate large-scale safety and efficacy data for a vaccine that is greatly needed in this region.”

On April 25, World Malaria Day, UN Chief António Guterres said: “Despite the Covid-19 pandemic and the multiple crises it has sparked, a growing number of countries are approaching and achieving malaria elimination.

“With a robust political commitment, adequate investment and the right mix of strategies, malaria can be defeated. We are committed to showing the world that a malaria-free future is possible,” Guterres asserted.

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