CORONAVIRUS | U.S. FDA Advisory Panel Sets Stage For Moderna Vaccine Authorization

The U.S. Food and Drug Administration (FDA) will ‘rapidly’ work towards granting emergency approval of Moderna Inc’s COVID-19 vaccine candidate, FDA Commissioner Stephen Hahm said on Thursday.

A panel of outside advisers to the FDA overwhelmingly endorsed the emergency use of Moderna’s coronavirus vaccine on Thursday, virtually assuring a second option for protecting against COVID-19 for a pandemic ravaged nation.

The committee voted 20-0 with one abstention that the benefits of the vaccine outweighed its risks in people aged 18 and older.

A week ago, the same panel backed a vaccine from Pfizer Inc and German partner BioNTech SE, leading to an FDA emergency use authorization (EUA) a day later.

Following Hahn’s comments, the Financial Times reported that the FDA had decided to approve Moderna’s vaccine candidate on an emergency basis. It cited people close to the process and added that the emergency approval will be granted in coming days.

The FDA and Moderna did not immediately respond to requests for comment on the Financial Times report.

The FDA si expected to grant EUA late on Thursday or Friday.

EASIER TO TRANSPORT AND STORE

Modern’a vaccine does not require specialized ultra – cold freezer or vast quantities of dry ice, unlike Pfizer’s vaccine which needs to be shipped and stored at -70 Celsius (-94F), making it easier to supply rural and remote areas. 

Moderna said on Thursday it had expanded the vaccine’s handling guidance to allow it to be moved locally in a liquid state at standard refrigerated temperatures. In some cases, Moderna said, this could be the only practical way to move it to clinics or remote locations.

U.S. officials have said they expect to have 40 million does of the Pfizer/BioNTech and Moderna vaccines by the end of the year – enough to inoculate 20 people. Both vaccines were about 95% effective at preventing illness in pivotal clinical trials with no serious safety issues.

The first wave of doses are expected to be earmarked for healthcare workers who treat COVID-19 patients and vulnerable residents and staff of nursing homes. The Moderna vaccine, based on new synthetic messenger RNA (mRNA) technology, is administered in two shots about 28 days apart. The Pfizer/BioNTech shot is also an mRNA vaccine.

Documents prepared by FDA scientists and released ahead of the meeting, said a two – dose regimen of the Moderna vaccine was highly effective preventive in preventing COVID-19 and did not raise any specific safetly issues.

There were no cases of severe COVID-19 among those who got the vaccine in the trial versus 30 such cases in the placebo group, which could be significant as hospital intensive care units fill with infected patients.

The United States in August entered a $1.5 billion pact with Moderna to acquire 100 million does  of its vaccine.

About 20 million does are expected to be delivered this month, with the rest of the initial purchase coming in the first quarter of next year. Last week, Moderna agreed to deliver an addition 100 million doses in the second quarter.

In the global race to produce highly effective vaccines against the coronavirus, the Massachusetts – based biotech company  is reaching the finish line ahead of some much larger rival such as AstraZeneca Pla and Johnson $ Johnson.

An emergency meeting of a U.S Centers for Disease Control and Prevention advisory panel is expected to follow the FDA’s authorization of Moderna’s vaccine with its official recommendation of its use for the U.S. public.

Saudi – Led Coalition Says It Intercepts Houthi Drone Fired At Southern Saudi Arabia

The Saudi – led coalition fighting Houthi forces in Yemen said on Tuesday it had destroyed an explosive drone fired towards Khamis Mushait in the south of Saudi Arabia. A military spokesman for the Iran – aligned Houthi group then said they had fired a drone at and hit Abha International Airpot, which is near … More Saudi – Led Coalition Says It Intercepts Houthi Drone Fired At Southern Saudi Arabia

Saudi Arabia’s Crown Prince, China’s Xi Discuss Cooperation In Phone Call

China’s President Xi Jinping told Saudi Arabia’s Crown Prince Mohammed bin Salman on Tuesday that Beijing was willing to push its strategic partnership with Riyadh ‘to a new level’, the official Chinese Xinhua news agency reported. In a phone call, the two leaders discussed boosting cooperation in energy, trade and technology, Xinhua added. China’s crude … More Saudi Arabia’s Crown Prince, China’s Xi Discuss Cooperation In Phone Call

Saudi Arabia’s King Salman, Crown Prince Donate Total of $7.9 Mln To Charity

Saudi Arabia’s King Salman bin Abdulaziz and Crown Prince Mohammed bin Salman have donated a total of $7.9 million (SR 30 million) to charity through the Kingdom’s Ehsan Platform, the Saudi Press Agency (SPA) reported on Friday. King Salman donated $5.3 million (SR20 million) for charitable and non – profitable works, while the Crown Prince contributed … More Saudi Arabia’s King Salman, Crown Prince Donate Total of $7.9 Mln To Charity

U.S. Imposes Wide Array Of Sanctions On Russia For ‘Malign’ Actions

The Unites States on Thursday imposed a boar array of sanctions on Russia to punish it for election interference, cyber – hacking, bullying Ukraine and other ‘malign’ acts. The measures blacklisted Russian companies, expelled Russian diplomats and placed limits on the Russian sovereign debt market in steps sure to anger Moscow. Among the actions, President … More U.S. Imposes Wide Array Of Sanctions On Russia For ‘Malign’ Actions

Queen Elizabeth Returns To Royal Duties Four Days After Her Husband’s Death – PM Media

Britain’s Queen Elizabeth return to royal duties on Tuesday, four days after the death of her husband, Prince Philip, in an event to mark the retirement of her household’s most senior official, PA Media reported. The queen hosted a ceremony as the Earl Peel stepped down as Lord Chamberlain, the report added. Philip, who has … More Queen Elizabeth Returns To Royal Duties Four Days After Her Husband’s Death – PM Media

Saudi Arabia’s Ithra Celebrates Ramadan With Cultural Events, Activities

Saudi Arabia’s King Abdulaziz Center for World Culture (Ithra) is celebrating the holy month of Ramadan with a wide selection of cultural events and interactive activities. Ithra is offering visitors a chance to take part in events focused on national traditions and  Saudi Arabian heritage, as well as different interactive workshops. The centre’s Ramadan program also includes a collection … More Saudi Arabia’s Ithra Celebrates Ramadan With Cultural Events, Activities

Britain’s Prince Philip Has Died

Prince Philip, the husband of Queen Elizabeth who played a leading  figure in the British royal family for almost seven decades, has died aged 99, Buckingham Palace said on Friday. The Duke of Edniburgh, as he was been y his wife’s side through her 69-year  reign, the longest in British history, during which time he … More Britain’s Prince Philip Has Died

Former Secretary Of State Pompeo To Join Fox News Media

Former U.S. Secretary of State Mike Pompeo will join Fox News Media as a contributor, the news network controlled by media baron Rupert Murdoch said on Thursday. Pompeo is the latest former Trump administration official to join the network. Other notable names include former White House secretary Kayleigh McEnany and Trump’s top economic adviser Larry … More Former Secretary Of State Pompeo To Join Fox News Media

Saudi Arabia’s Crown Prince Announces Opening Of Sakaka Power Plant

Saudi Arabia’s Crown Prince Mohammed bin Salman announced the opening of the Sakaka IPP PV power plat, the Kingdom’s first renewable energy project, the Saudi Press Agency (SPA) reported on Thursday. The launch of the Sakaka IPP PV and the signing power purchase agreements (PPA) for seven new projects are the result of King Salman’s … More Saudi Arabia’s Crown Prince Announces Opening Of Sakaka Power Plant

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