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S.Africa allows use of Merck COVID pill but government not buying

S.Africa allows use of Merck COVID pill but government not buying

ALEXANDER WINNING SOUTH Africa's government said it was not planning to buy Merck's COVID-19 treatment pill molnupiravir for cost reasons, despite the drug gaining approval from the country's health regulator. Molnupiravir and a rival antiviral pill from Pfizer called Paxlovid have demonstrated efficacy in trials of adults with COVID-19 who are at high risk of serious illness and are now both in use. Countries around the world are negotiating prices with Merck and Pfizer. The U.S. government is paying $700 for each course of molnupiravir, but generic drugmakers will make cheap versions in a deal aimed at giving access to poorer…
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South African regulator approves Sinopharm COVID vaccine

South African regulator approves Sinopharm COVID vaccine

SOUTH Africa's health regulator said on Monday it had approved a COVID-19 vaccine from China's Sinopharm, although a senior health official said the government was not planning to procure doses for now. South Africa, the country worst hit by the pandemic in Africa in terms of reported COVID-19 infections and deaths, has used the Pfizer-BioNTech and Johnson & Johnson (J&J) shots in its vaccination campaign. The government delayed some vaccine deliveries late last year because of oversupply as hesitancy slowed the uptake. Drugs regulator SAHPRA said in a statement the Sinopharm approval was based on "acceptable safety, quality and efficacy data…
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Sinovac in talks about setting up S.Africa vaccine production

Sinovac in talks about setting up S.Africa vaccine production

CHINA’S Sinovac Biotech is in talks about setting up a vaccine production facility in South Africa with its local partner, the chief executive of Numolux said on Friday. Hilton Klein made the comments at the launch of the South African leg of a global Phase III trial of Sinovac's COVID-19 vaccine in children and adolescents. "This clinical trial is a precursor to the establishment of a South African vaccine manufacturing facility partnered by Sinovac and Numolux Group that will cover the entire spectrum of vaccinations beyond just the COVID-19 response," Klein told a news conference. "We are in talks with…
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Vaccine trials for SA children

Vaccine trials for SA children

CHINA’S Sinovac Biotech will trial its COVID-19 vaccine in children and adolescents in South Africa as part of a global Phase III study, according to Sinovac and its local partner Numolux Group. The study will evaluate the efficacy, immunogenicity and safety of the CoronaVac vaccine on children and adolescents aged 6 months to 17 years, the firms said in a statement. The global trial will enrol 14,000 participants across Chile, the Philippines, Malaysia and Kenya, including 2,000 in South Africa, they said. The trial has been approved by South African drugs regulator SAHPRA, and the first child will be vaccinated…
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S.A assess efficacy of Sinopharm vaccine

S.A assess efficacy of Sinopharm vaccine

SOUTH Africa's health regulator has received documentation for China's Sinopharm COVID-19 vaccine and will evaluate the data to assess the efficacy of the shot. Now in the grip of a third wave of infections, South Africa is inoculating its population with Johnson & Johnson and Pfizer vaccines, but the rollout has been slow partly due to setbacks in supply. It has vaccinated just over 2 million people, 3.6% of its population, one of the world's lowest rates. Authorities have faced pressure from South African radical opposition party the Economic Freedom Fighters to authorise the use of Russian and Chinese vaccines…
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SA holds back unsuitable vaccines

SA holds back unsuitable vaccines

South African health inspectors have said they will not release Johnson & Johnson COVID-19 vaccines that may have been contaminated during production at a U.S. plant. The South African Health Products Regulatory Authority (SAHPRA) said it made the decision after the U.S. Food and Drug Administration (FDA) raised concerns over manufacturing practices at the Baltimore plant. "SAHPRA reviewed the data provided by the FDA and has made a decision not to release vaccine produced using the drug substance batches that were not suitable," SAHPRA said in a statement. The findings by the FDA would impact two million vaccines that are…
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‘J&J shot can be given to pregnant women’

‘J&J shot can be given to pregnant women’

SOUTH Africa's drug regulator has said that Johnson & Johnson's COVID-19 vaccine can be given to pregnant women with co-morbidities or at high risk of contracting the coronavirus. The South African health ministry said SAHPRA had previously said pregnant and breastfeeding women should be excluded from a local research study evaluating the J&J vaccine's efficacy. That research study, which aims to immunize 500,000 health workers, resumed on Wednesday after it was temporarily suspended over extremely rare cases of blood clots in people given J&J's vaccine in the United States. But in recommendations posted on its website on Thursday, the regulator…
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Lifting of J&J vaccine pause recommended

Lifting of J&J vaccine pause recommended

SOUTH Africa's health regulator has recommended that the government lift the pause on administering drugmaker Johnson & Johnson's COVID-19 vaccines, given that certain conditions are met. "These conditions include, but are not limited to, strengthened screening and monitoring of participants who are at high risk of a blood clotting disorder," the South African Health Products Regulatory Authority (SAHPRA) said. "In addition, measures are to be implemented to ensure the safe management of any participants who develop vaccine-induced thrombosis and thrombocytopenia (VITT)," the statement added. SAHPRA said on Wednesday that it had recently reviewed data from Johnson & Johnson's local research…
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SA health regulator registers J&J’s COVID-19 vaccine

SA health regulator registers J&J’s COVID-19 vaccine

SOUTH Africa's health regulator has registered Johnson & Johnson’s  COVID-19 vaccine, paving the way for deliveries to start in the second quarter. The registration of J&J's vaccine is a boost for the country worst affected by the pandemic on the continent in terms of recorded infections and deaths. South Africa is counting on J&J to supply 31 million doses of its vaccine. J&J said in a statement that the South African Health Products Regulatory Authority (SAHPRA) had "granted registration with conditions" for its single-dose vaccine. SAHPRA's spokesman confirmed that J&J's vaccine had been registered when called by Reuters. He said…
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SA approves vaccine for emergency use

SA approves vaccine for emergency use

SOUTH Africa's drugs regulator SAHPRA said yesterday that it had approved a "section 21" emergency use application for the COVID-19 vaccine developed by Pfizer and BioNTech. SAHPRA added in a statement that the approval was subject to further efficacy and safety surveillance of the vaccine in the country, including monitoring its efficacy against the dominant local coronavirus variant. South Africa is the hardest-hit country on the African continent in terms of recorded coronavirus cases and deaths and suffered a severe second wave of infections driven by the more infectious 501Y.V2 variant, first identified late last year. It kick-started its vaccination…
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