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.

BREAKING NEWS | Saudi Crown Prince Receives Phone Call From French President Macron

RIYADH – – Saudi Arabia’s Crown Prince Mohammed bin Salman has received a phone call from French President Emmanuel Macron in which they discussed bilateral relations. ‘During the call, they reviewed relations between the two countries and opportunities for joint cooperation. Regional and international developments were discussed, and a number of issues of common interest … Continue reading BREAKING NEWS | Saudi Crown Prince Receives Phone Call From French President Macron

BREAKING NEWS | Saudi To Reopen Qatar Embassy In Coming Days – Saudi Minister

RIYADH – – Saudi Arabia expects to re-open its embassy in Qatar in the coming days, Saudi’s foreign minister said on Saturday, following a U.S.-backed détente last week in a three – year-old dispute between Arab states. It is just a matter a logistics, Saudi Arabia’s Foreign Minister Faisal bin Farhan told journalists in Riyadh … Continue reading BREAKING NEWS | Saudi To Reopen Qatar Embassy In Coming Days – Saudi Minister

SPORTS | Formula One Season Set To Start In Bahrain After Australian Grand Prix Postponement

MILAN – – The start of the Formula One season has been delayed after the Australian Grand Prix was postponed from March to November because of the COVID-19 pandemic.The Australian race in Melbourne has been rescheduled from March 21 to November 21. The Chinese GP has also been delayed but no new date has been … Continue reading SPORTS | Formula One Season Set To Start In Bahrain After Australian Grand Prix Postponement

BREAKING NEWS | Investments In Saudi Arabia’s Economy Will Reach Six Trillion Dollars: Crown Prince

AL ULA – – Saudi Arabia’s Crown Prince Mohammed bin Salman says major investment opportunities in Saudi Arabia will amount to six trillion dollars over the next ten years, including 3 trillion dollars in investments in new projects, within the framework of the opportunities provided by Vision 2030, reported Saudi Press Agency. Saudi Arabia’s Crown … Continue reading BREAKING NEWS | Investments In Saudi Arabia’s Economy Will Reach Six Trillion Dollars: Crown Prince

TRAVEL | Saudi Arabia Warns Citizens Against Travel To 12 Countries Without Approval Over Virus Fears

RIYADH – – Saudi Arabia warned on Wednesday its citizens against travel without prior approval to 12 countries where the coronavirus pandemic is still not under control.The Interior Ministry said the countries were Libya, Syria, Lebanon, Yemen, Iran, Turkey, Somalia, Armenia, Congo, Afghanistan, Venezuela and Belarus.It added that the same permission applies to other countries … Continue reading TRAVEL | Saudi Arabia Warns Citizens Against Travel To 12 Countries Without Approval Over Virus Fears

ROYALS | Oman Sultan’s Eldest Son Dhi Yazan To Succeed Him, Becoming First Crown Prince

RIYADH – – Oman’s Sultan Haitham will be succeeded by his eldest son Dhi Yazan, according to a new basic law published on Tuesday that creates a new position of crown prince and established succession from ruler to the eldest son. Sultan Haitham bin Tariq Al-Said has announced plans for the constitutional change on Monday, … Continue reading ROYALS | Oman Sultan’s Eldest Son Dhi Yazan To Succeed Him, Becoming First Crown Prince

SOCIAL MEDIA | YouTube Suspends Trump’s Channel After Violating Policy On Inciting Violence

Alphabet Inc.’s YouTube said on Tuesday it has suspended Donald Trump’s channel as it violated policies for inciting violence after last week’s assault on the U.S. Capitol by the president’s supporters. Online platforms and social media companies are distancing themselves from, and taking action against, those that encouraged or engaged in the violence in Washington, … Continue reading SOCIAL MEDIA | YouTube Suspends Trump’s Channel After Violating Policy On Inciting Violence

BREAKING NEWS | Saudi Crown Prince Congratulates Romanian PM, On Winning President, Parliament Confidence

RIYADH – – HRH Prince Mohammad bin Salman bin Abdulaziz Al Saud, Crown Prince, Deputy Prime Minister and Minister of Defense, has sent a cable of congratulations to Prime Minister of Romanian Florin Citu on obtaining the confidence of the Romanian President as well as the parliament for the office of the prime minister.  HRH … Continue reading BREAKING NEWS | Saudi Crown Prince Congratulates Romanian PM, On Winning President, Parliament Confidence

BREAKING NEWS | Saudi King Congratulates Romanian PM, on Winning President, Parliament Confidence

RIYADH — The Custodian of the Two Holy Mosques King Salman bin Abdulaziz Al Saud sent a cable of congratulations to the Romanian Prime Minister Florin Citu, on obtaining the confidence of His Excellency Romanian President as well as the parliament for the office of the Prime Minister. In his cable, the King expressed sincere … Continue reading BREAKING NEWS | Saudi King Congratulates Romanian PM, on Winning President, Parliament Confidence

BREAKING NEWS | Saudi Arabia Welcomes Washington’s Designation Of Houthis As Terrorist

RIYADH – – Saudi Arabia welcomed on Monday the American admiration’s decision to designate the Iran – backed Houthi militias and their leaders as terrorist. In a statement, the Foreign Ministry said the move is in line with the ‘demands of the legitimate Yemeni government to rein in the Houthis over their violations that have … Continue reading BREAKING NEWS | Saudi Arabia Welcomes Washington’s Designation Of Houthis As Terrorist

NEWS ALERT | Oman To Get Its First Crown Prince In Constitutional Overhaul

MILAN – – Oman’s sultan announced on Monday  a constitutional shakeup that includes the appointment of crown price for the first time and new rules on how parliament will work, state media said. A new basic law issued by Sultan Haitham Bin Tariq al – Said also emphasizes the role of the state in guaranteeing … Continue reading NEWS ALERT | Oman To Get Its First Crown Prince In Constitutional Overhaul

BREAKING NEWS | Saudi Crown Prince Receives Italian FM in AlUla

AL ULA – – Crown Prince Mohammed bin Salman, Deputy Prime Minister and Minister of Defense, received in AlUla on Sunday Italian Foreign Minister Luigi Di Maio. Talks focused on bilateral relations and the promising opportunities to develop them in all fields. They also tackled regional and international dedvelopments. The meeting was attended by Saudi … Continue reading BREAKING NEWS | Saudi Crown Prince Receives Italian FM in AlUla

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