FDA asks Pfizer to test second Paxlovid course in patients with COVID-19 rebound

FDA asks Pfizer to test second Paxlovid course in patients with COVID-19 rebound
The US Food and Drug Administration. (AP/File)
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Updated 22 August 2022

FDA asks Pfizer to test second Paxlovid course in patients with COVID-19 rebound

FDA asks Pfizer to test second Paxlovid course in patients with COVID-19 rebound
  • The regulator said a formal plan for the clinical trial is expected to be finalized this month

DUBAI: The US Food and Drug Administration (FDA) has ordered Pfizer Inc. to test the effects of an additional course of its antiviral Paxlovid among people who experience a rebound in COVID-19 after treatment, the regulator said on Friday.
The drugmaker must produce initial results of a randomized controlled trial of a second course of the antiviral by Sept. 30 next year, the FDA told Pfizer in a letter dated Aug. 5.
The regulator said a formal plan for the clinical trial is expected to be finalized this month.
Pfizer is “working with the FDA to finalize a protocol to study patients who may be in need of retreatment,” and will provide details when available, a company spokesperson said.


Zelensky discredits Russian referendums, thanks Saudi Crown Prince for prisoner swap’s ‘brilliant result’

Zelensky discredits Russian referendums, thanks Saudi Crown Prince for prisoner swap’s ‘brilliant result’
Updated 47 min 34 sec ago

Zelensky discredits Russian referendums, thanks Saudi Crown Prince for prisoner swap’s ‘brilliant result’

Zelensky discredits Russian referendums, thanks Saudi Crown Prince for prisoner swap’s ‘brilliant result’
  • Nuclear threats by Chechen leader Ramzan Kadyrov ‘should not be taken seriously,’ says Ukrainian president
  • Iran slammed for lying and continuing to send kamikaze drones for use against Ukraine
  • Arab countries and business welcome to invest and contribute to rebuilding Ukrainian cities and sectors 

RIYADH: Volodymyr Zelensky, the Ukrainian president, has called Russian President Vladimir Putin’s referendums and accords formally recognizing the annexation of territories in eastern Ukraine a “bloody PR-(stunt) based on human victims.”

“I’m not sure what kind of referendums they had. We don’t have any such referendums in Ukraine. We don’t have any law even for that purpose,” Zelensky told Frankly Speaking host Katie Jensen in an exclusive interview via Zoom video link from Kyiv.

Referendums across Luhansk, Donetsk, Zaporizhzhia and Kherson saw an overwhelming majority voting to join the Russian Federation, in a process that many international observers believe was rigged.

Zelensky also rebuffed Putin’s recent claims of major victories on the battlefield. Just last week, Ukrainian forces retook the strategic eastern town of Lyman located in one of the four regions annexed by Russia, prompting Moscow to announce the “withdrawal” of its troops to “more favorable lines.”

“What they declare is clearly different from what they can do. They said they will occupy our territory, our nation. But in eight months of the war, I can tell you that we won back yet another city, the city of Lyman in Donetsk Oblast, exactly the one that Russia declared as fully occupied a couple of days ago,” said Zelensky.

“I can assure Russia and the Russian people that, unlike Russia, we are not interested in Russian territories. We are interested in our territory, in our borders based on the international recognition from 1991.”

Zelensky speaking to Frankly Speaking host Katie Jensen in an exclusive interview via Zoom video link from Kyiv. (Screenshot/AN Photo)

The war in Ukraine has shaken the region and the global geopolitical and economic order due to shifts in the trade of energy, the rising cost of oil and gas, and the reconfiguration of supply chains.

More than six million Ukrainians fled to nearby countries. Meanwhile, diplomatic tensions have mounted as nations are pressed to choose a side. There is also growing concern for global food security.

News of Putin’s annexation of four Ukrainian regions has put world leaders on edge once more, as there appears to be no clear end to the war in sight. 

For Zelensky, there are three components that will contribute to Ukraine’s eventual success.

“I think it’s a great victory for any nation worldwide when its people are united and people are able to leave some minor squabbles and historical discrepancies. This is very important,” he said.

“Another important step is that we are advancing against the world’s second biggest army, and we are able to show that the true strength is in unity, not in armaments.

“The third victory is, we have been able to unite Europe and the whole world. You know, before it was much more like everyone stands for him or herself. Now we see this unification and we see that there will be many more challenges also internationally, and there will be more of them.”

Despite Zelensky’s note of optimism, Moscow has vowed to never give up its newly annexed areas and to defend them with all means available. Ramzan Kadyrov, leader of the Chechen Republic, has even gone so far as to suggest the use of low-grade nuclear weapons in Ukraine.

Zelensky dismissed these threats, branding Kadyrov a “terrorist who was not even elected by his own people.”

“This is not serious. Come on. In (the) modern world, how can someone threaten others with nuclear weapons? Yeah, we have lots of terrorists worldwide. We have killers, but I cannot condescend to talk to a terrorist like that,” he said.

Since the annexations, Zelensky has signed a request asking for the acceleration of the process of Ukraine joining NATO. However, many skeptics view this as a futile request, especially given the response from Washington did not signal any immediate action.

On Saturday, US National Security Adviser Jake Sullivan said the US believes Ukraine’s NATO application “should be taken up at a different time.”

“Right now, our view is that the best way for us to support Ukraine is through practical, on-the-ground support in Ukraine and that the process in Brussels should be taken up at a different time,” said Sullivan.

In spite of this, Zelensky said countries should “pay attention just to the facts, not just to the words.”

Crown Prince Mohammed bin Salman during a meeting with Ukrainian President Volodymyr Zelenskyy’s Special Envoy Rustem Umerov in September. (SPA)

“We had statements from 10 allies, NATO members, with full support for Ukraine,” he said. The country should join NATO “as soon as possible.”

“I would rather say not when, in terms of time, but in terms of geography. I think it might happen when we will be standing at our borders.”

Meanwhile, the Ukrainian actor-turned-wartime leader also repeated his rejection of Putin’s offer to negotiate, firmly reiterating that he will only negotiate with a different president.

“We did warn them, if you want to launch these fake referendums, there will be no further talks with the president of the Russian Federation, for if the Russian president cannot respect the law, international law, the constitution, and by the way, not just our constitution, but that of his own country, he should not be violating our territorial integrity if this happens,” Zelensky said.

“Am I in a position to talk to him? He’s not a president.”

However, there does seem to be room for mediation and initiatives that could help to solve different pressing issues such as prisoner swaps and the release of Black Sea grain from Ukraine’s southern ports.  

Just last month, Saudi Arabia brokered a prisoner swap between Russia and Ukraine, playing an important diplomatic role between the warring nations.

Saudi Arabia’s Crown Prince Mohammed bin Salman last month held successful mediation sessions to release ten prisoners from various countries from Russia. (SPA)

“I’d like to thank Saudi Arabia for the effort,” said Zelensky. “Given the ties that the crown prince has with Russia, probably it was, you know, a good chance of success, and I’m very much thankful to him for this brilliant result.”

The deal saw almost 300 people, including 10 foreigners, returned to their homelands, the first of very few breakthroughs since the war began.

The Saudi Foreign Ministry said at the time that the initiative was based on the support of Crown Prince Mohammed bin Salman, and in continuation of his efforts to adopt humanitarian initiatives toward the Russia-Ukraine crisis.

“We are open to any proposals when it is about the results to be achieved, the results of such efforts,” said Zelensky. 

While Saudi Arabia has been trying to mediate, Iran has been accused of lying to top Ukrainian officials and selling drones to Russia.

Ukrainian forces shot down Iranian kamikaze drones sold to Russia in an effort to target civilians, which led Zelensky to dismiss Iranian diplomats from the country.

“It is sad that we have to recognize that the Iranian government is lying, as the Russian Federation government is, because we had contact with Iran’s leaders at the topmost level. We talked to the embassy, we had the ambassadors called up to the Ministry of External Affairs, and we were assured that nothing was sold to Russia, it wasn’t their drones, and nothing of the kind,” he said.

During his interview, Zelensky rebuffed Putin’s recent claims of major victories on the battlefield. (AN Photo/Screenshot)

“We have a number of these downed Iranian drones, and these have been sold to Russia to kill our people, and they are — you’re right — they are being used against civilian infrastructure and civilians, peaceful civilians. Because of that, we sent Iranian diplomats away from the country. We have nothing to talk with them about.”

While the war rages on, Zelensky has also been looking to the future and insists there are big opportunities for Arab nations to invest in the rebuilding of Ukraine.

“We would really love to see Arab businesses, and (for) Arab countries to be present, working in our country. We are ready to offer wonderful terms and conditions for businesses, fiscal, and so on. And there is also one ambitious aim for every country willing to come to Ukraine with an idea of recovery.”

“There will be a possibility for private companies, for Arab countries as well, because it is about rebuilding — recovering the whole of the state, of the nation.”

However, a recent Arab News/YouGov study conducted in May showed that a majority (66 percent) of Arabs felt indifferent toward the Russia-Ukraine conflict. Furthermore, a majority of respondents from the Arab world expressed a view that the blame for the war lies not with Russia but with US President Joe Biden and with NATO for not allowing Ukraine to join years ago — a finding Zelensky challenged. 

“Truly, this war was started by Russia, and Russia is the only one to blame. What else could the united West do to avoid it? Maybe they could do more, but to blame the US, that they, the war is because of them, this is not just, this is not true. Only Russia is guilty of that,” he said.

Among countries in the GCC, Levant and North Africa, although NATO is perceived more often as the party responsible for the conflict, the apportioning of blame is more balanced. People in the Gulf states, for example, blame NATO (23 percent) only marginally more than they do Russia (19 percent).

Despite opting to condemn Russian aggression during a UN vote last March, major Arab countries, such as Saudi Arabia, Egypt and the UAE, have remained largely neutral, and expressed a desire to mediate between Moscow and Kyiv. 

Arab News Disclaimer

* It is important to note that since the beginning of this war, Arab News has reached out numerous times to various Russian officials for comment. Most recently the newspaper also reached out to the Ministry of Foreign Affairs official spokesperson, Maria Zakharova, to appear on Frankly Speaking.

To date, all of our interview requests have fallen on deaf ears. However, Arab News wishes to reiterate that in our adherence to our professional duty, Ms. Zakharova’s invitation to appear on Frankly Speaking remains open, and the program looks forward to having her on this show whenever she accepts.

 


Burkina putsch leader urges end to violence on French targets

Burkina putsch leader urges end to violence on French targets
Updated 03 October 2022

Burkina putsch leader urges end to violence on French targets

Burkina putsch leader urges end to violence on French targets

OUAGADOUGOU: Burkina Faso’s new self-proclaimed putsch leader on Sunday called for an end to violence against French targets, after a series of attacks against buildings linked to the former colonial power.

“Things are progressively returning to order, so we urge you to freely go about your business and to refrain from any act of violence and vandalism ... notably those that could be perpetrated against the French Embassy and the French military base,” an officer said, reading on television from a statement from Captain Ibrahim Traore, who stood by his side.

Dozens of supporters of Traore gathered at the French Embassy in the capital. Security forces fired tear gas from inside the compound to disperse the protesters after they set fire to barriers outside and lobbed rocks at the structure, with some trying to scale the fence.

The latest unrest began on Friday, when junior military officers announced they had toppled the country’s junta leader, sparking deep concern among world powers over the latest putsch to hit the Sahel region battling a growing insurgency.

Late on Saturday, the junta leader, Paul-Henri Sandaogo Damiba, said he had no intention of giving up power and urged the officers to “come to their senses.”

His comments came shortly after the army general staff dismissed the coup as an “internal crisis” within the military and said dialogue was “ongoing” to remedy the situation.

The capital remained tense overnight, with demonstrators gathering on the main roads of Ouagadougou as a helicopter hovered above.

In a statement read out on television on Sunday, the officers who claimed the coup said they had lifted a curfew they had imposed and called for a meeting of ministry heads for later in the day.

The officers had accused Damiba of having hidden at a military base of former colonial power France to plot a “counteroffensive,” charges that he and France denied.

The French Foreign Ministry condemned “the violence against our embassy in the strongest terms” by “hostile demonstrators manipulated by a disinformation campaign against us.”

It marked the latest incident against a France-linked building in two days, after a fire at the embassy on Saturday and a blaze in front of the French Institute in the western city of Bobo-Dioulasso. A French institute in the capital also sustained major damage, the ministry said.


Trump staffers not returning White House records, National Archives says

Trump staffers not returning White House records, National Archives says
Updated 03 October 2022

Trump staffers not returning White House records, National Archives says

Trump staffers not returning White House records, National Archives says
  • FBI seized more than 11,000 records, including about 100 classified documents, in a court-approved search

WASHINGTON: Former President Donald Trump’s administration has not turned over all presidential records and the National Archives will consult with the Justice Department on whether to move to get them back, the agency has told Congress.
A congressional panel on Sept. 13 sought an urgent review by the National Archives and Records Administration after agency staff members acknowledged that they did not know if all presidential records from Trump’s White House had been turned over.
“While there is no easy way to establish absolute accountability, we do know that we do not have custody of everything we should,” acting Archivist Debra Wall said in a letter Friday to the House Committee on Oversight and Reform.
The Archives knows some White House staffers conducted official business on personal electronic messaging accounts that were not copied or forwarded to their official accounts, in violation of the Presidential Records Act, Wall said.
“NARA has been able to obtain such records from a number of former officials and will continue to pursue the return of similar types of presidential records from former officials,” Wall said in the letter, first reported by the Wall Street Journal.
She said the Archives, the federal agency charged with preserving government records, would consult with the Department of Justice on “whether to initiate an action for the recovery of records unlawfully removed.”
The Oversight Committee shared a copy of the letter with Reuters but has not issued a statement on it yet.
Representatives for Trump did not immediately return a request for comment on the matter.
Trump is facing a criminal investigation by the Justice Department for retaining government records — some marked as highly classified, including “top secret” — at his Mar-a-Lago estate in Florida after leaving office in January 2021.
The FBI seized more than 11,000 records, including about 100 documents marked as classified, in a court-approved Aug. 8 search at Mar-a-Lago.
The Justice Department and Trump’s lawyers have been locked in a legal battle over how the records are handled. Government lawyers have been granted access to the classified documents but on Friday asked an appeals court to expedite its ability to access the non-classified documents seized in Florida.

Read More: NY probe found potential crimes. Why isn't Trump in cuffs?


French march in Paris to rally support for women in Iran

French march in Paris to rally support for women in Iran
Updated 02 October 2022

French march in Paris to rally support for women in Iran

French march in Paris to rally support for women in Iran
  • Some women cut off chunks of their hair in protest

PARIS: Thousands of people marched in Paris on Sunday to show their support for Iranian protesters standing up to their leadership over the death of a young woman in police custody. Several female demonstrators chopped off chunks of their hair and tossed them into the air as a gesture of liberation.
Women of Iranian heritage, French feminist groups and leading politicians were among those who joined the gathering at Republique Plaza before marching through eastern Paris.
“Woman, Life, Liberty!” the crowd chanted, undeterred by the rainy weather. Some banners read: “Freedom for Iranian women,” or “No to Obligatory Hijab” or just the young woman’s name: “#Mahsa Amini.”
It was the latest and appeared to be the largest of several protests in France in support of the Iranian demonstrators. Iranians and others have also marched in cities around the world.
Thousands of Iranians have taken to the streets over the last two weeks to protest the death of Mahsa Amini, a 22-year-old woman who had been detained by Iran’s morality police in the capital of Tehran for allegedly not adhering to Iran’s strict Islamic dress code.
The protesters have vented their anger over the treatment of women and wider repression in the Islamic Republic, and the demonstrations escalated into calls for the overthrow of the clerical establishment that has ruled Iran since 1979.
At the Paris protest, some chanted in Persian and French, “Khomenei get out!” — referring to Iran’s supreme leader Ayatollah Khomenei. Some women’s cheeks bore drawings of a red poppy, the symbol of a martyr in Iran.
Iris Farkhondeh, a 40-year-old French scholar who came to France as a refugee when she was a toddler, said she worries about rising Islamist extremism and the risk of terrorist attacks in France by religious extremists.
“The battle we fight in Iran is the same as that in France,” she said.
Other protesters described anger at Iran’s dress codes and encroaching restrictions on women. Some were afraid to give their names out of concerns for repercussions for family members in Iran.
Romane Ranjbaran, 28, came to protest with her mother and other family members.
”Iran is part and parcel of my history. My mom knew free Iran, when women were free,” she said.
She said she was happy to see so many people at Sunday’s gathering.
“It is an international fight. If we want the situation in Iran to improve, we need international support,” she said.


Greece says it’s open to talks with Turkey once provocations end

Greece says it’s open to talks with Turkey once provocations end
Updated 02 October 2022

Greece says it’s open to talks with Turkey once provocations end

Greece says it’s open to talks with Turkey once provocations end
  • “It is up to Turkey to choose if it will come to such a dialogue or not, but the basic ingredient must be a de-escalation,” Dendias said

ATHENS: Greece wants to have a constructive dialogue with Turkey based on international law but its Aegean neighbor must halt its unprecedented escalation of provocations, the Greek foreign minister said on Sunday.
The two countries — North Atlantic Treaty Organization (NATO) allies but historic foes — have been at odds for decades over a range of issues, including where their continental shelves start and end, overflights in the Aegean Sea and divided Cyprus.
“It is up to Turkey to choose if it will come to such a dialogue or not, but the basic ingredient must be a de-escalation,” Nikos Dendias told Proto Thema newspaper in an interview.
Last month, the European Union voiced concern over statements by Turkish President Tayip Erdogan accusing Greece, an EU member, of occupying demilitarised islands in the Aegean and saying Turkey was ready to “do what is necessary” when the time came.
“The one responsible for a de-escalation is the one causing the escalation, which is Turkey,” Dendias said.
He blamed Ankara for increased provocations with a rhetoric of false and legally baseless claims, “even personal insults.”
Turkey has sharply increased its overflights and violations of Greek airspace, Dendias told the paper, adding that its behavior seems to be serving a “revisionist narrative” that it promotes consistently.
He said Turkish claims that Greece cannot be an equal interlocutor diplomatically, politically and militarily violates the basic rule of foreign relations — the principle of euality among nations.
“It is an insulting approach that ranks various countries as more or less equal,” Dendias said.