KEMRI studying effectiveness of Moderna vaccine in adults over 40 years


Efforts to further research and develop vaccines locally continue with KEMRI set to commence within the month of August, a ground-breaking research on the Moderna vaccine that could help inform its entry into Kenya’s government program.

The study will target 250 participants for 12 months, adults aged above 40 with comorbidities, pregnant women aged above 18, and adults aged above 18 living with H.I.V.

The objectives of the study are : to assess vaccine efficacy to prevent symptomatic COVID-19, starting 14 days after dose 2 in adults at risk of severe COVID-19, to assess vaccine efficacy to prevent severe COVID-19 starting 14 days after dose 2 in adults at risk of severe COVID-19 and to assess safety and tolerability of vaccine in adults who are at risk of covid-19.

Of the 54 sites where the similar study is being, 2 are in Kenya in Kisumu and Moi university, 33 in South Africa and others in Uganda, Malawi and Zimbabwe .

“All the groundwork and approvals have been done. “We will follow up for 12 months, so it will be 17 months once it starts.” Frank Angira, Research Investigator KEMRI says.

This, just but one of the earliest phases in Kenya’s push to manufacture and distribute COVID-19 vaccines locally.

“ We have to get signatures for research . Then test the samples on both animals and humans before we do the actual testing, before the actual manufacture and rollout. We already have 2 candidate vaccines,” Professor Sam Kariuki, acting Director General KEMRI says.

Kenya is looking to adopt a fill and finish factory model, where the country imports vaccines in bulk, repackages them and then distributes them.

“It will take us up to 6 months to 1 year to have companies waive their IP so that we can also import vaccines in bulk, and also donate their seed to propagate so that we can have local manufacturing capacity.” Prof. Kariuki added.

Pfizer and Biontech have struck a deal for South Africa’s Biovac Institute, based in Cape Town to help manufacture around 100 million doses a year in 2022 of their Covid-19 vaccine for the African Union.

The deal is to “fill and finish” the vaccine, the final stages of manufacturing where the product is processed and put into vials.

It does not cover the complicated processes of Mrna drug substance production, which Pfizer and Biontech will do at their own facilities in Europe.

Biovac will receive a large batch of ingredients for the vaccine from europe and will blend the components, put them in vials and package them for distribution.

“I think it’s historic for an African manufacturing, for us as a continent.So for us we’d like to act as quickly as possible so already within this week, we’re going to start putting orders on items that are known that we can put orders. So we want to act as quickly as possible, bearing in mind that the Pfizer vaccine is already being rolled out at the moment like in South Africa.” Morena Makhoana, CEO Biovac said.

But the bottleneck is that Moderna is handled under -70 degrees Celsius. Which means that if Biovac manufactures the product, it has to go into -70 freezers, for which there is a need to build facilities for Biovac’s manufacturing site before the vaccines actually get transported.

The agreement comes as Pfizer and Biontech try to sway two members from supporting a waiver on some intellectual property rights for COVID-19 vaccines.

 

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