Medical body’s legal battle with trade union continues

Business Day 22 March 2021 - Dispute between the SA Medical Association and the SA Medical Association Trade Union is about deductions, which the union claims belong to it

A judgment handed down by the Constitutional Court last week did not mean that the non-profit professional body representing medical doctors and medical students was required to immediately pay millions of rand to the trade union representing doctors in the public sector, it said on Friday. The SA Medical Association (Sama) and the SA Medical Association Trade Union (Samatu) have been in a long-standing dispute over whether Sama owes Samatu millions of rand in deductions paid over the past 20 years. Samatu, which is under administration, has applied for Sama’s liquidation saying that it owes as much as R370m, but Sama is opposing this. 

Boris Johnson tries to defuse vaccine tension with EU

Business Day 22 March 2021 - Prime minister says he feels reassured after talks with European partners over several months that they do not want to see vaccine blockades

British Prime Minister Boris Johnson has said the EU does not want to launch a vaccine battle, despite the bloc warning it is set to restrict exports of coronavirus shots to the UK.  In an attempt to defuse the tensions with Brussels, Johnson said avoiding blockades of vaccine supplies is vital because immunisation programmes require countries to work together. The comments underline his government’s position that the EU should keep to its earlier promises not to get in the way of exports to the UK. The tone he struck was conciliatory even as political tempers flared. 

AstraZeneca vaccines sale concluded, says health ministry

Business Day 22 March 2021 - The sale became necessary once SA decided to pivot to the Johnson & Johnson vaccine study

SA has sold the AstraZeneca vaccines it had initially planned to roll out to South Africans, the ministry of health said on Sunday, emphasising that the money for the transaction had been received. The ministry said in a statement health minister Zweli Mkhize was pleased to announce that the sale of the AstraZeneca vaccines SA had acquired had been concluded. The announcement came a day before Reuters reported on Monday that the AstraZeneca and Oxford University's coronavirus vaccine received a major boost as data from a large trial showed it was safe and effective. 

AU urges states to continue use of AstraZeneca vaccine

Business Day 18 March 2021 - Recommendation comes several European countries suspended use of the AstraZeneca shots

he AU said on Thursday that African countries should continue to use AstraZeneca's Covid-19 vaccine, echoing the World Health Organization (WHO) by saying the shot's benefits outweighed risks. The recommendation comes after several European countries suspended use of the AstraZeneca vaccine amid concerns over the risk of blood clots. Africa has lagged wealthier parts of the world in vaccinations, with many countries on the continent using free AstraZeneca shots distributed by a global scheme co-led by the WHO to kick-start immunisation campaigns. 

UK says SII vaccine delays add to supply squeeze

Business Day 18 March 2021 - The Serum Institute of India, which makes the AstraZeneca shot, says it will supply more based on the needs of the vaccine programme in India

Britain is facing a squeeze on supply of Covid-19 vaccines in April in part due to a delay in a shipment from the Serum Institute of India (SII) that makes AstraZeneca’s shot, health minister Matt Hancock said on Thursday. Britain has been conducting the fastest rollout of inoculations by a major economy but health officials said on Wednesday that the programme would face a significant reduction in supplies from March 29, without initially specifying where the problems were. 

Should we be worried about blood clots and AstraZeneca’s vaccine?

Business Day 18 March 2021 - Probably not, as there are only 30 reported cases from more than 17-million doses of the vaccine being given in the UK and EU

Europe’s drug watchdog is reviewing a small number of reports of bleeding, blood clots and low platelet counts in people who have received AstraZeneca’s coronavirus vaccine. The European Medicines Agency (EMA) has said it has so far found no causal link between the vaccine and the incidents. The World Health Organization (WHO) has also said there is no proven link and people should not panic. At least 13 EU member states including Germany, France, Italy have suspended use of the shot pending the outcome of the EMA’s probe. 

State-backed Biovac clinches deal with ImmunityBio to make Covid-19 vaccines

Business Day 18 March 2021 - If the phase 1 trial demonstrates the vaccine elicits a response, larger phase 2 and 3 trials will be conducted during the year

State-backed vaccine manufacturer Biovac has entered into a partnership with California-based ImmunityBio for local production of its candidate Covid-19 vaccine, it announced on Thursday. The agreement is strategically important because it paves the way for Biovac to develop the expertise to manufacture active pharmaceutical ingredients (APIs), said CEO Morena Makhoana. There is currently no vaccine API production in SA, and local pharmaceutical manufacturers, such as Biovac and Aspen Pharmacare, fill and package vaccines formulated by other firms. “Strategically, if we want to make a long-term impact, we have to look at API manufacturing,” said Makhoana. Biovac anticipated building the capacity to produce vaccine APIs for both the domestic and export market, he said. 

SAHPRA approves emergency use application for Pfizer vaccine

Medical Brief 17 March 2021 - South Africa‘s drugs regulator SAHPRA has announced that it had approved a conditional “section 21” emergency use application for the COVID-19 vaccine developed by Pfizer and BioNTech. 

SAHPRA added 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. 

Sinovac offers 5-million coronavirus vaccines to SA

Business Day 17 March 2021 - The CoronaVac shot has not yet been approved in SA, but if it is, delivery could come within weeks

Chinese coronavirus vaccine manufacturer Sinovac Biotech has offered to supply the government with 5-million doses of its CoronaVac shot, which could be provided within weeks, its local partner Numolux said. Chinese coronavirus vaccine manufacturer Sinovac Biotech has offered to supply the government with 5-million doses of its CoronaVac shot, which could be provided within weeks, its local partner Numolux said. Sinovac’s vaccine requires two doses, administered two weeks apart. 

No room for corruption in vaccine procurement and rollout, says Mabuza

Business Day 17 March 2021 - There is limited room for corruption in the acquisition and rollout of the Covid-19 vaccines, deputy president David Mabuza told parliament on Wednesday.

The government’s response to the pandemic has been rocked by corruption allegations in recent months. The Special Investigating Unit (SIU) has been probing various suspicious Covid-19 contracts in provinces such as Gauteng, the Eastern Cape and KwaZulu-Natal after widespread allegations of nepotism and corruption largely linked to personal protective equipment (PPE). The graft allegations have prompted the National Treasury to look into the possible centralisation of procurement. Responding to questions in the National Assembly on Wednesday, Mabuza, the chair of the interministerial committee on vaccines, said the government has put in place mechanisms to make it easier to report acts of corruption related to Covid-19 procurement. 

Medical scheme members not keen to pay for others’ vaccines

Business Day 17 March 2021 - Only half of respondents back the government’s proposal for the private sector to subsidise inoculation

Only half of SA’s medical scheme members back a government proposal that they help fund Covid-19 vaccines for non-members, according to a survey by the industry regulator. The results reflect division within the medical schemes industry, which has yet to agree with the government on how it might help fund the vaccine rollout. The most likely mechanism is that medical schemes will pay a premium on the price the government pays to vaccine manufacturers, but it is still not clear how the premium will be set. The Treasury allocated R10.3bn for the government’s vaccination programme in the budget, but indicated in February that it anticipates some funding will come from the private sector. The government’s vaccination strategy aims to inoculate 40-million adults, of whom an estimated 7.1-million belong to medical schemes. 

HPCSA suspends 16 implicated in SIU corruption probe

Medical Brief 17 March 2021 - The Health Professions Council of SA (HPCSA) has placed 16 employees on precautionary suspension, after they were implicated in bribery and corruption involving the expediting of registration processes.

The HPCSA said the suspensions followed findings in an investigation into maladministration, corruption and fraud that had been under way since 2019, notes News24. The investigation, undertaken by the Special Investigating Unit, was approved by President Cyril Ramaphosa at the request of the HPCSA. 

Medicines regulator gives nod for Pfizer’s coronavirus shot to be administered in SA

Business Day 16 March 2021 - Section 21 authorisation is subject to close monitoring of the safety and efficacy of the vaccine, Sahpra says

SA’s medicines regulator has granted a Section 21 authorisation for the Pfizer/BioNTech Covid-19 vaccine, clearing the way for the shot to be imported and administered before it has been registered in SA. Section 21 of the Medicines and Related Substances Act allows the SA Health Products Regulatory Authority (Sahpra) to grant permission for the administration of unregistered medicines, provided they have been approved by a stringent regulator such as the US Food and Drug Administration or the European Medicines Authority. It has yet to finalise Pfizer’s application to register its Covid-19 vaccine, branded Comirnaty. While Sahpra’s announcement means a key regulatory hurdle has been cleared, it still remains an open question when Pfizer’s vaccines will arrive in SA. 

Better vaccines coming including ones that don’t use needles

Business Day 15 March 2021 - New treatments will add to the 10 already shown to work within a year of Covid-19 being declared a pandemic

New Covid-19 vaccines, including ones that don’t require needles and can be stored at room temperature, may be ready for use later this year or next year, the World Health Organisation’s top scientist said. Six to eight new immunisations may complete clinical studies and undergo regulatory review by the end of the year, Soumya Swaminathan, the Geneva-based agency’s chief scientist, said in an interview. New vaccines will add to the 10 already shown to work within a year of Covid-19 being declared a pandemic. 

Regular Covid-19 booster vaccines will be standard procedure

Business Day 15 March 2021 - The novel coronavirus mutates about once every two weeks — slower than influenza or HIV, but enough to require tweaks to vaccines

Regular booster vaccines against the novel coronavirus will be needed because of mutations that make it more transmissible and better able to evade human immunity, the head of Britain’s effort to sequence the virus’s genomes told Reuters. The novel coronavirus, which has killed 2.65-million people globally since it emerged in China in late 2019, mutates about once every two weeks, slower than influenza or HIV, but enough to require tweaks to vaccines. Sharon Peacock, who heads Covid-19 Genomics UK (COG-UK) which has sequenced half of all the novel coronavirus genomes so far mapped globally, said international co-operation was needed in the “cat and mouse” battle with the virus.