(Reuters) -Pfizer Inc said on Thursday it is seeking full U.S. approval for its oral COVID-19 antiviral treatment Paxlovid, which is currently available under an emergency use authorization (EUA).

Pfizer said it submitted a New Drug Application for Paxlovid to the Food and Drug Administration for the treatment of COVID-19 in vaccinated and unvaccinated people at high risk of progression to severe illness.

That is basically consistent with the drug’s current EUA, which Pfizer said covers 50% to 60% of the U.S. population, citing estimates from the U.S. Centers for Disease Control and Prevention.

A full approval could mean the company would have the option to sell Paxlovid on the open market like other drugs, depending on whether or not the U.S. government decides to stop buying the drug and providing it for free nationwide.

Also, “the company might have more control over educating the public with commercials, or however they want, to boost uptake,” said Karen Andersen, healthcare strategist at Morningstar.

The two-drug treatment taken for five days beginning shortly after onset of COVID symptoms reduced the risk of hospitalization or death by 88% in non-hospitalized, high-risk adult patients in Pfizer’s clinical trial, which did not included vaccinated people.

Data from a study in Israel earlier this month showed Paxlovid reduced COVID-19 hospitalization and death rates in vaccinated and unvaccinated patients 65 years and older, but was not found to prevent severe illness among younger adults.

More than 1.6 million courses of Paxlovid have been administered in the United States, according to data from the Department of Health and Human Services.

(Reporting by Michael Erman and Manas MishraEditing by Bill Berkrot and Mark Potter)

By Andrew Chung

WASHINGTON -On the heels of last week’s landmark ruling expanding individual gun rights, the U.S. Supreme Court on Thursday threw out several lower court rulings that had upheld gun restrictions including bans on assault-style rifles in Maryland and large-capacity ammunition magazines in New Jersey and California.

The actions by the justices sent these cases back to lower courts to reconsider in light of their June 23 ruling that declared for the first time a constitutional right to carry a handgun in public for self defense.

Last week’s 6-3 ruling, with the conservative justices in the majority and liberal justices in dissent, struck down New York state’s limits on carrying concealed handguns outside the home. The court found that the law, enacted in 1913, violated a person’s right to “keep and bear arms” under the Second Amendment.

The ruling also clarified how courts must now assess whether regulations are valid under the U.S. Constitution’s Second Amendment, requiring them to be comparable with restrictions traditionally adopted throughout U.S. history. Legal experts say – and gun control advocates fear – such a standard could lead courts to invalidate more gun restrictions nationwide.

The justices’ actions on Thursday mean that lower courts that allowed gun restrictions will have to reconsider decisions including one upholding Maryland’s ban on “highly dangerous, military-style assault rifles.”

Maryland enacted its ban after a shooter used such a weapon in the 2012 mass killing of 20 children and six adults at Sandy Hook Elementary School in Newtown, Connecticut. Five other states also ban these weapons, Maryland said in a legal filing.

Assault-type rifles have been a recurring feature in U.S. mass shootings in recent years including the May 24 attack that killed 19 children and two teachers at an elementary school in Uvalde, Texas, and the May 14 attack that killed 10 people at a grocery store in Buffalo, New York.

The Maryland plaintiffs sued in 2020 despite conceding that their case was doomed under a 2017 ruling by the Richmond, Virginia-based 4th U.S. Circuit Court of Appeals, which had upheld Maryland’s ban. The Supreme Court declined to hear an appeal of that ruling.

Contesting the term “assault weapon” as an inaccurate “political term,” the Maryland plaintiffs said that assault weapons cannot be outright banned because they are in “common use” by millions of law abiding individuals, just like the handguns at issue in the landmark 2008 Supreme Court ruling striking down a ban on the firearms in the U.S. capital.

The justices sent back to lower courts other rulings upholding bans in New Jersey and California on firearm magazines with more than 10 rounds of ammunition. The challenges in those cases were filed by state affiliates of the National Rifle Association, a gun rights group closely aligned with Republicans.

The Supreme Court also threw out a lower court decision that had upheld Hawaii’s restrictions on openly carrying firearms in public as valid under the Second Amendment.

Gun rights, cherished by many Americans and promised by the country’s 18th century founders, are a contentious issue in a nation with high levels of firearms violence.

Last week’s ruling represented the court’s most important statement on gun rights in more than a decade. The court in 2008 recognized for the first time an individual’s right to keep guns at home for self-defense in a District of Columbia case, and in 2010 applied that right to the states.

President Joe Biden, two days after the court invalidated New York’s gun measure, signed into law last Saturday the first major federal gun reform in three decades.

The new law blocks gun sales to those convicted of abusing unmarried intimate partners and cracks down on gun sales to purchasers convicted of domestic violence. It also provides new federal funding to states that administer “red flag” laws intended to remove guns from people deemed dangerous to themselves and others.

It does not ban sales of assault-style rifles or high-capacity magazines, policies Biden supports. But it does take some steps on background checks by allowing access, for the first time, to information on significant crimes committed by juveniles.

(Reporting by Andrew Chung; Editing by Will Dunham)

By Andrew Chung

WASHINGTON -The U.S. Supreme Court on Thursday agreed to hear a Republican-backed appeal that could give state legislatures far more power over federal elections by limiting the ability of state courts to review their actions, taking up a North Carolina case that could have broad implications for the 2024 elections and beyond.

The justices took up the appeal by Republican state lawmakers of a February decision by North Carolina’s top court to throw out a map delineating the state’s 14 U.S. House of Representatives districts approved last year by the Republican-controlled state legislature.

The North Carolina Supreme Court determined that the boundaries for the districts were drawn by the legislature in a manner that boosted the electoral chances of Republicans at the expense of Democrats. It rejected Republican arguments seeking to shield legislature-drawn maps from legal attack in state courts.

North Carolina House Speaker Timothy Moore, a Republican, hailed the high court’s decision to hear the appeal.

“This case is not only critical to election integrity in North Carolina, but has implications for the security of elections nationwide,” Moore said.

Voting rights advocates disagreed.

“In a radical power grab, self-serving politicians want to defy our state’s highest court and impose illegal voting districts upon the people of North Carolina,” said Bob Phillips, executive director of Common Cause, a voting rights group that is among the plaintiffs challenging the legislature’s map.

In March, the U.S. Supreme Court rejected a Republican request to put on hold the lower court rulings that adopted the court-drawn map, a decision seen as boosting Democratic hopes of retaining their slim House majority in the November midterm elections. Conservative Justices Samuel Alito, Clarence Thomas and Neil Gorsuch dissented from that decision.

The Republican lawmakers said the state court impermissibly imposed its own policy determination for how much partisanship can go into crafting congressional lines. They acknowledged that the case would have an impact beyond redistricting, extending to “the whole waterfront of voting issues, from absentee voting deadlines to witness requirements, voter ID to curbside voting.”

The U.S. Supreme Court will hear the case in its next term, which begins in October, with a decision due by June 2023. The ruling is not expected to come before this November’s elections but could apply to 2024 elections including the presidential race.

Two groups of plaintiffs, including Democratic voters and an environmental group, sued after North Carolina’s legislature passed its version of the congressional map last November. The plaintiffs argued that the map violated the North Carolina state constitution’s provisions concerning free elections and freedom of assembly, among others.

The North Carolina Supreme Court struck down the map on Feb. 4, concluding that the way the districts were crafted was intentionally biased against Democrats, diluting their “fundamental right to equal voting power.”

A lower state court on Feb. 23 rejected a redrawn map submitted by the legislature and instead adopted a new map drawn by a bipartisan group of experts. According to some redistricting analysts, the new map includes seven Republican districts likely to be won by Republicans, six likely to be won by Democrats and one competitive seat.

NUMEROUS LEGAL BATTLES

The dispute is one of numerous legal battles in the United States over the composition of electoral districts, which are redrawn each decade to reflect population changes measured in a national census, last taken in 2020. In most states, such redistricting is done by the party in power, which can lead to map manipulation for partisan gain.

The Supreme Court in 2019 barred federal judges from curbing the practice, called partisan gerrymandering. Critics have said that such gerrymandering warps democracy.

The North Carolina Republicans’ defense of the legislature’s map relies on a contentious legal theory called the “independent state legislature doctrine” that is gaining traction in conservative legal circles and, if accepted, would vastly increase politicians’ control over how elections are conducted.

Under that doctrine, the U.S. Constitution gives legislatures, not state courts or other entities, authority over election rules including the drawing of electoral districts.

The doctrine is based in part on language in the Constitution stating that the “times, places and manner” of federal elections “shall be prescribed in each state by the legislature thereof.” In their appeal to the Supreme Court, the Republican lawmakers decried the “state supreme court’s usurpation of that authority.”

The state’s Department of Justice said in a legal filing that, contrary to the Republican lawmakers’ assertions, North Carolina state law specifically authorizes state courts to review redistricting efforts.

(Reporting by Andrew Chung; Editing by Will Dunham)

JERUSALEM -Israel on Wednesday moved closer toward its fifth election in less than four years, plunging it deeper into political uncertainty as it grapples with rising living costs amid renewed international efforts to revive a nuclear deal with Iran.

Prime Minister Naftali Bennett announced he would not run in the upcoming election but would retain his position as alternate prime minister after his coalition partner Yair Lapid takes over as head of the caretaker government.

“I leave behind a thriving, strong and secure country,” he told reporters on Wednesday. “We proved this year that people with very different opinions can work together,” he added, referring to his ideologically diverse coalition.

Last week, Bennett moved to disperse parliament after a series of defections made his ruling coalition no longer tenable. The final vote on the bill to dissolve the Knesset, which was set to happen by midnight, was delayed until Thursday due to the many amendments filed, Israel’s public broadcaster Kan radio said.

Amendments were submitted by parties across the political spectrum. Israeli Finance Minister Avigdor Lieberman said his party was blocking the dispersal bill to advance a metro project, and the Arab-led Joint List party said it was hoping a holdup would lead to the expiration of regulations that extend legal protections to settlers in the occupied West Bank.

Once the calling of a snap election gets the Knesset’s final approval, Israel’s centre-left foreign minister, Yair Lapid, will take over from Bennett as prime minister of a caretaker government with limited powers.

But even with lawmakers grappling over the exact election date, either Oct. 25 or Nov. 1, the campaign has already become dominated by the possible comeback of former prime minister Benjamin Netanyahu.

Lapid and Bennett ended Netanyahu’s record 12-year reign a year ago by forming a rare, ideologically mixed alliance that included an independent Arab party for the first time. The government lasted longer than many expected but faltered in recent weeks amid infighting.

Netanyahu, now opposition leader, has been delighted by the end of what he has called the worst government in Israel’s history. He hopes to win a sixth term in office despite being on trial for corruption on charges he denies.

Surveys have shown his right-wing Likud party leading the polls but still short of a governing majority despite support of allied religious and nationalist parties.

Lawmakers from the pro-Netanyahu bloc have said they were working to form a new government before parliament dissolves. That scenario, which appears remote, would scupper an early election.

(Reporting by Maayan Lubell and Henriette Chacar; Editing by Robert Birsel and Aurora Ellis)

By Andrea Shalal, Aislinn Laing and Robin Emmott

MADRID -President Joe Biden said on Thursday the United States will provide another $800 million in weapons and military aid to Ukraine, hailing the courage of Ukrainians since Russia invaded in February.

Speaking after a NATO summit that saw the alliance also agree to take in Finland and Sweden, Biden said the United States and its NATO allies were united in standing up to Russian President Vladimir Putin.

“I don’t know how it’s going to end, but it will not end with Russia defeating Ukraine,” Biden told a news conference. “Ukraine has already dealt a severe blow to Russia.”

Biden, who appeared to be readying allies for a long conflict in Ukraine despite talk in March of a possible victory, added: “We are going to support Ukraine for as long as it takes.” He declined to give more details.

The pending formal announcement of more weapons would come on top of the more than $6.1 billion already announced by the United States since Russia forces rolled into Ukraine on Feb. 24 and brought full-scale war back to Europe.

The plans for fresh aid, as NATO repositions itself again on a Cold War footing with a massive forces build-up, came as Ukrainians used Howitzers to retake the strategic outpost of Snake Island.

Biden had earlier pledged more American troops, warplanes and warships for Europe as NATO agreed to strengthen its deterrents, putting more than 300,000 troops on high alert from the middle of next year.

“The U.S. is doing exactly what I said we would do if Russia invaded, enhance our force posture in Europe,” Biden said. “The United States is rallying the world to stand with Ukraine.”

RUSSIAN REPRISALS?

British Prime Minister Boris Johnson said London would provide another 1 billion pounds ($1.22 billion) in military aid to Ukraine, while his French counterpart Emmanuel Macron said France would soon deliver six more CAESAR guns.

Britain’s contribution includes air defence systems and new electronic warfare equipment, taking support to more than 2.3 billion pounds since Moscow’s invasion, a financial sum the British government said was second only to U.S. aid.

Putin did not appear ready to withdraw or negotiate the terms of a peace deal, Johnson said.

“There doesn’t seem to be anything to talk about. Because it’s not only that the Ukrainian people would find it very difficult to do a deal, Putin isn’t even offering a deal,” Johnson told a news conference.

In the biggest shift in European security in decades, Finland and Sweden will sign the formal accession protocol next Tuesday to join NATO, NATO Secretary-General Jens Stoltenberg said, although ratification by its 30 members’ parliaments could take a year.

Turkish President Tayyip Erdogan however told a news conference at the close of the summit that the Nordic nations must first keep the promises in a deal for Turkey to lift its veto on their NATO membership bids.

Erdogan said Sweden had promised to extradite 73 individuals that he described as terrorists.

“First Sweden and Finland should carry out their duties and those are in the text … But if they don’t, of course it is out of the question for the ratification to be sent to our parliament,” Erdogan said.

Putin said on Wednesday that Russia would respond in kind if NATO deployed troops or infrastructure in Finland or Sweden.

Estonian Prime Minister Kaja Kallas said the West needed to be ready, particularly in terms of possible attacks on Finnish, Sweden and NATO computer networks. “Of course, we have to expect some kind of surprises from Putin, but I doubt that he is attacking Sweden or Finland directly,” she said.

FIGHTING ON ALL FLANKS

While the three-day summit was dominated by NATO’s response to Russia’s war in Ukraine, host Spain urged allies to consider a bigger role for the alliance in North Africa and the Sahel.

NATO was created in 1949 to defend against the Soviet Union.

Western powers are concerned about a spike in violence in Mali, where the country’s ruling military junta, backed by Russian private military contractor Wagner Group, is battling an Islamist insurgency that spills into neighbouring countries in the African region known as the Sahel.

France, whose military policy has long been focused on NATO’s south, said in February that it would pull out 2,400 troops, after relations with the junta turned sour.

At Spain’s urging, with support from Italy, NATO’s new, 10-year master document, the “strategic concept” cites terrorism and migration as elements to monitor, and points to the southern flank as a new potential source of instability.

Spanish Foreign Minister Jose Manuel Albares said the region “is the epicentre of global terrorism”.

“If the threat were very present and very concrete, we could see a reinforcement of military deployment on the southern border as we are seeing in the east,” he said.

($1 = 0.8228 pounds)

(Additional reporting by Sabine Siebold, Humeyra Pamuk, Belen Carreno, Aislinn Laing, Andrea Shalal in Madrid, Alan Charlish in Warsaw and William James in London; Writing by Robin Emmott; Editing by Alison Williams)