The House She Built a Source of Conflict

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There was a time when everything seemed to be going right for Amara . She was a beautiful woman, not only in appearance but in the way she carried herself. She grew up in a loving home, surrounded by parents who worked hard and believed that their children should never lack opportunities. Her father was a respected man who worked tirelessly to provide for the family, while her mother was equally hardworking. They raised their daughters with discipline, kindness, and the belief that education and hard work were the keys to a good life. Amara was the elder daughter. Her younger sister, Nadia , was also intelligent and ambitious. The two sisters grew up watching their parents work together, and they learned an important lesson from them: nothing worthwhile comes without sacrifice. As the years passed, both sisters became successful in their own ways. Amara worked hard, saved her money, and eventually achieved something she had dreamed about since she was young. She bought a beauti...
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CAPE TOWN, Feb 15 (Reuters) - South Africa's drugs regulator SAHPRA said on Monday it has approved an implementation study of Johnson & Johnson's COVID-19 vaccine, clearing the way to start the country's first inoculations among health workers.

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 * Govt still reviewing J&J’s full market application

* Implementation study is to vaccinate health workers
* S.Africa expected to receive J&J’s vaccines this week (Adds detail, quotes)

By Wendell Roelf

South Africa is yet to start its COVID-19 vaccination programme and the government has decided to go with the J&J dose after trial results this month showed AstraZeneca’s two-shot vaccine was less effective against the new variant of the coronavirus dominating South African infections.

“SAHPRA has approved the implementation study,” the regulator said in response to Reuters questions, but added it was still reviewing its separate full market application.

The implementation study, similar to the final phase of a vaccine trial, will test the effects of the vaccine in the field after it is administered to around 350,000 to 500,000 health care workers.

The first batch of J&J’s 80,000 doses are expected to arrive this week, President Cyril Ramaphosa told lawmakers on Thursday.

J&J was the first pharmaceutical major to apply to the local regulator in December to register its COVID-19 vaccine, although Pfizer and AstraZeneca have also applied.

South Africa is currently the hardest hit African country and accounts for over a third of the continent’s infections and almost half of the deaths, led primarily by the new, more contagious variant called 501Y.V2.

The South African Health Products Regulatory Authority (SAHPRA) said J&J has not yet submitted a special domestic application for emergency use authorisation of its vaccine – known as a Section 21 application.

Normally valid for six months, Section 21 authorisation allows emergency use of a product that is unregistered, SAHPRA officials said.

However, J&J’s application for full market registration was being processed as part of a rolling review approach, which allows data to be evaluated by SAHPRA as it becomes available, the regulator said. “The rolling review has received its second batch of data and is under review. The full process is estimated to be complete after four batches of rolling data (are received),” said SAHPRA.

This is one of several methods the domestic regulator is pursuing to help fast-track vaccine approvals. (Reporting by Wendell Roelf; editing by Promit Mukherjee and Jason Neely)

Information pertaining to Covid-19, vaccines, how to control the spread of the virus and potential treatments is ever-changing. Under the South African Disaster Management Act Regulation 11(5)(c) it is prohibited to publish information through any medium with the intention to deceive people on government measures to address COVID-19. We are therefore disabling the comment section on this article in order to protect both the commenting member and ourselves from potential liability. Should you have additional information that you think we should know, please email letters@dailymaverick.co.za

 

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