NAIROBI, July 22 (Reuters) - Global pharmaceutical firms should license production of COVID-19 vaccines in Africa rather than just do piecemeal contract deals, an African Union special envoy said on Thursday.

AU coronavirus envoy Strive Masiyiwa was speaking a day after Pfizer and BioNTech announced a "fill and finish" deal with South Africa's Biovac Institute under which it will carry out the final stages of vaccine manufacturing where the product is processed and put into vials. read more

Pfizer and BioNTech will handle drug substance production at their facilities in Europe. Medecins Sans Frontieres (MSF) has called the arrangement "restrictive" and said much more is needed to support vaccine independence in Africa.

"We want to make clear to all suppliers ... if you want a long-term future with us now, you produce from Africa," Masiyiwa said.

Africa, which is battling a third wave of infections, has administered just 60 million vaccine doses in a population of 1.3 billion due to restrictions on shipments from vaccine producing nations like India.

Many African nations rely on global vaccine sharing scheme COVAX or donations from countries like China and India.

"For regions left behind in the vaccine race to be self- sufficient, they need access to all of the components of vaccine production," said Lara Dovifat, manager at MSF's access campaign, which is seeking equitable vaccine access.

Matshidiso Moeti, the head of the World Health Organization in Africa, called for local production of vaccines so Africa can tackle future outbreaks.

"We are looking beyond this crisis," she told a news conference.

Johnson & Johnson (JNJ.N), whose vaccine is administered through a single shot, also has a "fill and finish" deal with South Africa's Aspen Pharmacare (APNJ.J).

J&J is on track to supply members of the African Union with 400 million vaccine doses by September next year, Masiyiwa said.

Around 6 million doses will be delivered to 27 nations that have paid their share through the end of August, Masiyiwa said, with another 18 finalising loans from the World Bank and other global lenders before they make payment.

Deliveries will rise to an average of 10 million a month from September, increasing to 20 million in January until the order is fulfilled by September next year.

The balance of Africa's vaccine requirements will come from donors including COVAX, Masiyiwa said, adding that local production is the real answer.

"If you want land we will give you. If you want to own everything 100%, we don't mind, just produce from the African continent," he told the firms.

Writing by Duncan Miriri Editing by Giles Elgood

Our Standards: The Thomson Reuters Trust Principles.

Companies in Brazil and Senegal will produce antigen rapid tests for diagnosing Covid-19 from early 2022 under tech transfer agreements aimed at boosting availability in Latin America and Africa, international agencies said on Thursday.

High-quality antigen tests are the primary diagnostic tool for detecting active infection in poorer settings where molecular testing is not available, the global alliance for diagnostics FIND and health agency UNITAID said in a statement.

Agreements have been signed to transfer know-how from U.S.-based diagnostics company DCN Dx to WAMA Diagnóstica in Brazil, and from Bionote and Britain's Mologic -- known for the development of the clear blue pregnancy test -- to DIATROPIX of the Institut Pasteur de Dakar, the statement said.

It announced a separate partnership for commercialisation and distribution between Xixia Pharmaceuticals, a South African subsidiary of the generic drugmaker Viatris (VTRS.O), and Guangzhou Wondfo Biotech Co Ltd (Wondfo).

"Expanded production capacity in local and regional hubs is critical to ensuring that healthcare providers in low- and middle-income countries can implement effective testing strategies to contain the spread of the virus,” said UNITAID spokesman Herve Verhoosel.

WAMA Diagnostica is expected to generate test volumes of 2 million per month, with a ceiling price of $2.00 per test, he said.

The partnership between Wondfo, based in Guangzhou, China, and Xixia Pharmaceuticals, has the potential to produce 144 million tests per year at a ceiling price of $2.50 each, he added.

In Senegal, DIATROPIX will seek regulatory approval for the tests transferred from Mologic and Bionote and commercialise them under its own brand, aiming to make 2.5 million tests per month in 2022, the statement said.

Some 144 countries will be eligible for procurement through the ACT-A (Access to Covid-19 Tools Accelerator) scheme, it said.

Source - The East African

Uganda has approved the use of Covidex, a local herbal medicine, as a supporting treatment for viral infections, including Covid-19.

Addressing journalists in Kampala on Tuesday, National Drug Authority (NDA) executive director David Nahamya said after various assessments and inspection of the factory manufacturing the herbal medicine, they have approved its use to support treatment of viral infections.

"After engagements, the innovators have removed unsubstantiated claims that the product treats and prevents Covid-19 and revised it to supportive treatment in management of viral infections. NDA has granted Covidex an approval based on initial assessment, published literature and safety studies conducted by the innovator," Mr Nahamya announced.

The product has been formulated from herbal plants that have been traditionally used to alleviate symptoms of several diseases.

However, Mr Nahamya stressed that the medicine does not cure Covid-19 but it can supplement the medicine being used by medics to treat coronavirus patients.

The drug authority said it will continue to monitor the safety of Covidex through its post-market surveillance activities.

"We call upon the public to immediately report any side effects from the use of this product to our toll free line 0800101999," Mr Nahamya added.

The drug, made by Mbarara University scientists led by Prof Patrick Ogwang, had generated debate over its efficacy in treating the dreaded Covid-19.

But to further support the efficacy of the drug for other uses, NDA has advised the manufacturer to conduct random controlled clinical trials which are the highest level of evidence to ascertain any claims of treatment.

NDA had on June 14 asked the manufacturer of the drug to cease sales, citing safety concerns because the medicine had not yet been approved.

However, Daily Monitor reports that the drug, which users claim to be “very effective” against Covid-19 symptoms such as flu, is being ferried to various parts of the country as demand soars.

The Pharmaceutical Society of Uganda said there is still no proven cure for Covid-19 and all medicines (herbal and pharmaceutical) should be given equal chance.

Source - The East African

Rwanda has signed a Rwf3.6 billion ($3.6 million) partnership with the European Union to help upgrade the country’s laboratory capacity to help it attract investors to manufacture Covid-19 vaccines.

The funds will be used to strengthen the Foods and Drugs Authority's quality control for medical products, to enable the regulator acquire necessary certification from the World Health Organisation (WHO).

“What we signed is a step to revamp and also strengthen the Rwanda Foods and Drugs Authority. The money we will receive from the EU will support the acquisition of laboratory equipment to make it a modern facility that will enable Rwanda to get a WHO certification,” Clare Akamanzi, Chief Executive Officer, Rwanda Development Board told CNBC Africa on Thursday.

“The WHO certification we need for this will also build the confidence of investors who want to produce vaccines. They (investors) will be able to trust the regulatory capacity we want to strengthen with this funding.”

Production

Rwanda plans to start manufacturing coronavirus vaccines using mRNA technology after it secured international backing to build local capacity in the coming months.

Last week, Rwandan President Paul Kagame told the Qatar Economic Forum that the negotiations with partners to manufacture vaccines locally have advanced and the process will start “in a few months.”

He was speaking shortly after Rwanda, Senegal and South Africa were announced as potential candidates for hosting Africa’s regional Covid-19 vaccines production hubs.

“For Rwanda, in particular, we have partnered with some industries that are specialising in mRNA technology. So, we have already discussed that technology with people who will help with financing and I think in a few months we should hear a different story,” President Kagame said.

Africa, President Kagame added, has to be an equal partner with the rest of the world and manufacture vaccines as the continent continues to grapple with a blockage on supplies.

And while currently, South Africa, Egypt, Morocco, Tunisia, and Senegal have the capacity to produce Covid-19 vaccines, restrictions on intellectual property (IP) rights for Covid-19 vaccines has made it impossible.

Vaccine deliveries to Africa through the Covax facility ground to a near halt in May as the Serum Institute of India diverted doses for domestic use. Between February and May, the continent received just about a quarter – 18.2 million – of the 66 million expected doses through Covax, according to WHO.

"It’s not a question of if this was a moral failure, it was deliberate.

"Those with the resources pushed their way to the front of the queue and took control of their production assets," Strive Masiyiwa, African Union Special Envoy and coordinator of the Africa Vaccine Acquisition Task Team (AVATT) initiative, recently told a virtual summit by US-based Milken Institute on vaccine equality and equitable distribution.  

Masiyiwa expressed frustration that despite willingness by the Africa Union to pay upfront for the vaccines, he was told that manufacturers said “all capacity for 2021 has been sold.”

Support

In May 2021, the European Union announced at the G20 Global Health Summit that an initiative backed by $1.1 billion from its budget will be set to support manufacturing and access to vaccines and health technologies in Africa.

The statement also revealed that the EU and the European Investment Bank (EIB) are in discussions to partner with the government of Rwanda to facilitate and promote investment by pharmaceutical and biotech companies in the country, including exploring opportunities for co-financing potential investments.

“This is an important step in supporting local manufacturing of health products in Africa. Team Europe will continue to support the country and Africa in strengthening the regulatory framework and attracting investment in the pharmaceutical sector,” said Jutta Urpilainem, the European Commissioner for International Partnership. 

Third wave

While Covid-19 vaccination is currently ongoing across Africa, progress remains uneven and the pace remains too slow to significantly lower the risk of death or for the continent to achieve herd immunity as only 0.6 percent of Africa’s adult population is fully vaccinated according to estimates by the International Monetary Fund (IMF).

Now, concern is rising that the continent faces a real risk of catastrophe as it is now facing the World’s fastest growth rate for new Covid cases, with analysts at the IMF saying based on the current trends, the third wave will likely surpass previous peaks within the next week.

“It is a human tragedy and an economic calamity. Countries across the continent –from South Africa to Uganda and Rwanda – are forced to reintroduce restrictions, further denting a precarious recovery.

“In the face of new variants, Africa is ill protected, due to severe vaccine shortages. So far, only 0.6 percent of Africa’s adult population have been fully vaccinated…” said Ms Kristalina Georgieva, IMF Managing Director. She spoke at the African Development Bank Annual Meeting on June 23. 

Source - The East African