{"id":112862,"date":"2021-02-15T09:07:08","date_gmt":"2021-02-15T09:07:08","guid":{"rendered":"https:\/\/precoinnews.com\/?p=112862"},"modified":"2021-02-15T09:07:08","modified_gmt":"2021-02-15T09:07:08","slug":"jjs-vaccine-implementation-study-in-s-africa-gets-regulator-nod","status":"publish","type":"post","link":"https:\/\/precoinnews.com\/markets\/jjs-vaccine-implementation-study-in-s-africa-gets-regulator-nod\/","title":{"rendered":"J&J's vaccine implementation study in S.Africa gets regulator nod"},"content":{"rendered":"

CAPE TOWN (Reuters) – South Africa\u2019s drugs regulator SAHPRA said on Monday it has approved an implementation study of Johnson & Johnson\u2019s COVID-19 vaccine, clearing the way to start the country\u2019s first inoculations among health workers.<\/p>

FILE PHOTO: Vials labelled “COVID-19 Coronavirus Vaccine” and sryinge are seen in front of displayed Johnson&Johnson logo in this illustration taken, February 9, 2021. REUTERS\/Dado Ruvic\/Illustration<\/figcaption>

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\u2019s two-shot vaccine was less effective against the new variant of the coronavirus dominating South African infections.<\/p>\n

\u201cSAHPRA has approved the implementation study,\u201d the regulator said in response to Reuters questions, but added it was still reviewing its separate full market application.<\/p>\n

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.<\/p>\n

The first batch of J&J\u2019s 80,000 doses are expected to arrive this week, President Cyril Ramaphosa told lawmakers on Thursday.<\/p>\n

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.<\/p>\n

South Africa is currently the hardest hit African country and accounts for over a third of the continent\u2019s infections and almost half of the deaths, led primarily by the new, more contagious variant called 501Y.V2.<\/p>\n

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.<\/p>\n

Normally valid for six months, Section 21 authorisation allows emergency use of a product that is unregistered, SAHPRA officials said.<\/p>\n

However, J&J\u2019s 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.<\/p>\n

\u201cThe 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),\u201d said SAHPRA.<\/p>\n

This is one of several methods the domestic regulator is pursuing to help fast-track vaccine approvals.<\/p>\n

Source: Read Full Article<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

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