CORONAVIRUS | AstraZenca Aims To BRING Non – U.S. Vaccine Data Before The FDA

MILAN – – AstraZenca will start discussing emergency approval of its experimental COVID-19 vaccine with U.S. regulators one it has good trial fata from Britain, South Africa and Brazil, as it has no indication the watchdog would favour U.S. data.

If and when AstraZenca reaches the first statistically reliable efficacy and safety results from those trials, based on more than 25,000 volunteers in total, it would present them to the U.S. Food and Drug Administration (FDA) even though any read-out from an ongoing U.S. trial will be months later.

‘If you hit those thresholds we are going we are going to have a conversation with them’, executive team member Mene Pangalos told Reuters.

‘What the FDA has signaled is what their expectations of data are for an approval’, he said, adding the company had not spoken to the U.S. watchdog about where the data should some from.

The future of the U.S. trial would not be called into question by any successful non-U.S. trial result, Pangalos stressed.

Some experts have argued that, once a successful vaccine is widely available or soon expected, the runner-up in the vaccine race may find it difficult to recruit volunteers willing to risk being randomly assigned to a control group on placebo.

Pangalos said a vaccine would not be available for everyone immediately following approval. ‘That is not how it happens. It will take months to vaccinate people (widely)’, he said.

‘By the time the (U.K.) study reads out, we submit regulatory documents, and assuming we get an approval and the vaccine starts to be distributed across the U.S., I think there will be more than enough time to get the study almost fully recruited’.

‘Being on a vaccine study is probably going to be a good way…to get access to the vaccine’, he said, adding that only one in three U.S. trial participants will be on placebo.

Biden Imposes New International Travel Vaccine Rules, Lifts Existing

WASHINGTON – U.S. President Joe Biden on Monday signed an order imposing new vaccine requirements for most foreign national air travelers and lifting severe travel restrictions on China, India and much Europe effective Nob.8, the White House said. The extraordinary U.S. travel restrictions were first imposed in early 2020 to address the spread of COVID … More Biden Imposes New International Travel Vaccine Rules, Lifts Existing

Saudi Crown Prince Hosts The Middle East Green Initiative Summit

RIYADH, Saudi Arabia – Saudi Arabia’s Crown Prince Mohammed bin Salman will be hosting the first edition of the Middle East Green Initiative Summit in Riyadh where he will outline the Kingdom’s vision and the role of green financing in enabling the transition to green societies. During his opening address at the summit, the Crown Prince … More Saudi Crown Prince Hosts The Middle East Green Initiative Summit

Saudi Energy Minister Sees Demand From Gas – To – Oil Switch At Up To 600,000 BPD

LONDON – Saudi Arabia’s Minister of Energy Prince Abdulaziz bin Salman said users switching from gas to oil could account for demand of 500,000 – 600,000 barrels per day (bpd), adding that the world was now waking up to shortages in the energy sector. Prince Andulaziz said the potential switch depended on how severe winter … More Saudi Energy Minister Sees Demand From Gas – To – Oil Switch At Up To 600,000 BPD

Riyadh Winter Wonderland Back In Saudi Arabia, 40 Pct Larger Than Previous Season

RIYADH, Saudi Arabia –  Riyadh Winter Wonderland is set to make a comeback in Saudi Arabia’s capital with 40 percent more space during Riyadh Season, with added games, activities, and shows for all age groups. Starting October 26 and lasting until the end of March 2022, Winter Wonderland will include more than 103 games and six areas: Dreamland Carnival, … More Riyadh Winter Wonderland Back In Saudi Arabia, 40 Pct Larger Than Previous Season

Saudi Arabia Advises Citizens Not To Travel To Lebanon – Ministry

PARIS, France – Saudi Arabia has advised its citizens not to travel to Lebanon in light of the latest security events, the foreign ministry wrote on Twitter on Sunday. Lebanon remains on  a Saudi travel list where obtaining prior permission to visit is required. On Thursday, seven people were killed in violence in Beirut  as crowd … More Saudi Arabia Advises Citizens Not To Travel To Lebanon – Ministry

Saudi Arabia’s Crown Prince Launches Strategic Offices For Al – Baha, Al – Jouf, Jazan

JEDDAH, Saudi Arabia – Saudi Arabia’s Crown Prince Mohammed bin Salman announced on Sunday the launch of the strategic offices for the development of al – Baha, al – Jouf, and Jazan regions. According to the Saudi Press Agency (SPA), these offices aim to capitalize on the unique competitive advantages each of the three regions … More Saudi Arabia’s Crown Prince Launches Strategic Offices For Al – Baha, Al – Jouf, Jazan

Saudi Arabia Allows Full Capacity At Sports Stadiums, Facilities

PARIS, France – Saudi Arabia’s Ministry of Sports announced that vaccinated visitors will be allowed into all sports stadium and facilities as they operate at full capacity, the official Saudi Press Agency (SPA) reported Sunday. Visitor entry will be limited to those who are  fully vaccinated against COVID – 19, as per Kingdom’s rules, the … More Saudi Arabia Allows Full Capacity At Sports Stadiums, Facilities

Saudi Arabia Allows Capacity At Mecca’s Grand Mosque As COVID – 19 Rules Eased

PARIS, France – The Grand Mosque in the Muslim holy city of Mecca in Saudi Arabia operated at full capacity on Sunday, with worshippers praying shoulder – to – shoulder for the first time since the coronavirus pandemic began. This comes after Saudi Arabia’s Interior Ministry approved easing the country’s strict COVID – 19 precautionary … More Saudi Arabia Allows Capacity At Mecca’s Grand Mosque As COVID – 19 Rules Eased

Qatar Emir Appoints Two Women To Advisory Council After Men Sweep Polls

DOHA – Qatar’s emir named two women among his new appointment to the Gulf state’s advisory Shura Council on Thursday, after partial elections held for the first time earlier this month saw not one of the more than 20 women candidates a seat. In what was Qatar’s first legislative election, candidates competed for 30 of … More Qatar Emir Appoints Two Women To Advisory Council After Men Sweep Polls

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