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U.S. ends recommended pause on use

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U.S. health regulators on Friday lifted a recommended pause on the use of Johnson & Johnson‘s Covid-19 vaccine, giving state and local officials backing to distribute the doses, which are seen as critical in getting lifesaving shots to hard-to-reach communities.

The announcement from the Centers for Disease Control and Prevention and the Food and Drug Administration comes after the CDC’s Advisory Committee on Immunization Practices, known as ACIP, recommended earlier Friday for the continued use of the J&J vaccine, saying the benefits of the shot outweighed the risk. The committee is an outside panel of experts that advises the CDC.

Members of the advisory panel didn’t recommend U.S. regulators restrict the use of the J&J vaccine based on age or gender, but they did propose that the Food and Drug Administration consider adding a warning label for women under the age of 50.

In a statement late Friday, the FDA and CDC said they were confident that the vaccine is safe and effective in preventing Covid-19.

“Safety is our top priority,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement. “This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases.”

“We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices,” Woodcock said. “We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older.”

J&J’s Covid-19 vaccine, like Pfizer‘s and Moderna‘s shots, received an emergency use authorization from the FDA to start distributing the doses across the U.S. An EUA grants conditional clearance based on two months of safety data, pending another submission for full approval, which usually requires at least six months of data.

On April 13, the FDA and CDC asked states to temporarily halt using J&J’s vaccine “out of an abundance of caution” following reports that six women, ages 18 to 48, developed cerebral venous sinus thrombosis in combination with low blood platelets. CVST occurs when a blood clot forms in the brain’s venous sinuses. It can prevent blood from draining out of the brain and can eventually cause a hemorrhage and other brain damage.

Within hours of the warning from U.S. regulators, more than a dozen states, along with some national pharmacies, halted inoculations with J&J’s vaccine. Some locations replaced the J&J shots for scheduled appointments with either the Pfizer or Moderna vaccine.

The U.S. government was expected to lift the recommended pause shortly after the favorable vote from the committee.

Prior to Friday’s vote, the committee debated whether to recommend against the use of J&J’s vaccine or endorse it with U.S. regulators enforcing a warning label. The committee also considered limiting the vaccine’s use based on age or other risk factors.

During the meeting, CDC official Dr. Tom Shimabukuro said there have been no reports of the condition in those who received the Pfizer-BioNTech mRNA vaccine. There were three reports of CVST in patients who received the Moderna vaccine, he said, though the patients didn’t have the low level of blood platelets seen in the J&J recipients.

Blood platelets help the body form clots to heal wounds. U.S. health officials warned the use of a treatment like blood thinner heparin on those with low blood platelets could make their condition worse.

Rare blood clots with low platelets are occurring at a rate of 7 per 1 million vaccinations in women ages 18 to 49 for the J&J shot and 0.9 per 1 million in women age 50 and older, according to a slide presented at the CDC panel meeting. CDC has confirmed 15 cases total of rare blood clot conditions, which includes 12 women who developed blood clots in the brain. Three women died and 7 remained hospitalized, according to the presentation.

There are no confirmed cases in men, though officials have said they are reviewing potential additional cases.

Dr. Michael Streiff, a hematologist at Johns Hopkins University School of Medicine, said the condition, in normal circumstances, is very rare. “I can tell you from my experience, treating these patients, I’ve just never seen it,” he told the committee during a presentation Friday.

Earlier this week, J&J said it would resume the rollout of its vaccine in Europe after regulators there backed the single-shot vaccine with the recommendation that a warning be added to the label. The European Medicines Agency researched all available evidence, it said, including the reports from the United States.

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Here’s what you need to know

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People queue outside a vaccination center in Sydney on June 24, 2021, as residents were largely banned from leaving the city to stop a growing outbreak of the highly contagious Delta Covid-19 variant spreading to other regions.

SAEED KHAN | AFP | Getty Images

The “delta variant” has come to dominate headlines, having been discovered in India where it provoked an extreme surge in Covid-19 cases before spreading around the world.

But now a mutation of that variant has emerged, called “delta plus,” which is starting to worry global experts.

India has dubbed delta plus a “variant of concern,” and there are fears that it could potentially be more transmissible. In the U.K., Public Health England noted in its last summary that routine scanning of Covid cases in the country (where the delta variant is now responsible for the bulk of new infections) has found almost 40 cases of the newer variant, which has acquired the spike protein mutation K417N, i.e. delta plus.

It noted that, as of June 16, cases of the delta plus variant had also been identified in the U.S. (83 cases at the time the report was published last Friday) as well as Canada, India, Japan, Nepal, Poland, Portugal, Russia, Switzerland and Turkey.

India third wave?

As is common with all viruses, the coronavirus has mutated repeatedly since it emerged in China in late 2019. There have been a handful of variants that have emerged over the course of the pandemic that have changed the virus’s transmissibility, risk profile and even symptoms.

Read more: The fast-spreading delta Covid variant could have different symptoms, experts say

Several of those variants, such as the “alpha” strain (previously known as the “Kent” or “British” variant) and then the delta variant, have gone on to be dominant strains globally, hence the attention on delta plus.

India’s Health Ministry reportedly said Wednesday that it had found around 40 cases of the delta plus variant with the K417N mutation. The ministry released a statement on Tuesday in which it said that INSACOG, a consortium of 28 laboratories genome sequencing the virus in India during the pandemic, had informed it that the delta plus variant has three worrying characteristics.

These are, it said: increased transmissibility, stronger binding to receptors of lung cells and the potential reduction in monoclonal antibody response (which could reduce the efficacy of a lifesaving monoclonal antibody therapy given to some hospitalized Covid patients).

India’s Health Ministry said it had alerted three states (Maharashtra, Kerala and Madhya Pradesh) after the delta plus variant was detected in genome-sequenced samples from those areas.

The detection of a variation to the delta variant largely blamed for India’s catastrophic second wave of cases has stoked fears that India is ill-prepared for a potential third wave. But some experts are urging calm.

Dr. Chandrakant Lahariya, a physician-epidemiologist and vaccines and health systems expert based in New Delhi, told CNBC on Thursday that while the government should remain alert to the progress of the variant, there is “no reason to panic.”

“Epidemiologically speaking, I have no reason to believe that ‘Delta plus’ alters the current situation in a manner to accelerate or trigger the third wave,” he told CNBC via email.

“If we go by the currently available evidence, Delta plus is not very different from Delta variant. It is the same Delta variant with one additional mutation. The only clinical difference, which we know till now, is that Delta plus has some resistance to monoclonal antibody combination therapy. And that is not a major difference as the therapy itself is investigational and few are eligible for this treatment.”

He advised the public to follow Covid restrictions and to get vaccinated as soon as possible. Analysis from Public Health England released last week showed that two doses of the PfizerBioNTech or Oxford-AstraZeneca Covid-19 vaccines are highly effective against hospitalization from the delta variant.

The WHO has said it is tracking recent reports of a “delta plus” variant. “An additional mutation … has been identified,” Maria Van Kerkhove, WHO’s Covid-19 technical lead said at a briefing last week.

“In some of the delta variants we’ve seen one less mutation or one deletion instead of an additional, so we’re looking at all of it.”

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Booking volumes increase 45% over Q1

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The cruise ships “Carnival Sunrise” (L) and “Carnival Vista” (R) part of the Carnival Cruise Line, are seen moored at a quay in the port of Miami, Florida, on December 23, 2020, amid the Coronavirus pandemic. (Photo by Daniel SLIM / AFP) (Photo by DANIEL SLIM/AFP via Getty Images)

DANIEL SLIM | AFP | Getty Images

Carnival Corporation saw booking volumes increase 45% in the second quarter of this year compared to the first quarter, the cruise operator announced in a business update on Thursday

Carnival also said its cumulative advanced bookings for 2022 are ahead of its 2019 bookings, indicating the company expects a solid return to business after the pandemic shut down the cruise industry.

However, Carnival reported an adjusted net loss of $2 billion for the second-quarter of 2021. It expects a net loss on an adjusted basis for the third quarter and full year as well.

The company’s monthly cash burn rate for the first half of 2021 was $500 million.

Due to several outbreaks aboard cruise ships last year, the cruise industry was one of the last sectors allowed to resume operations.

The Centers for Disease Control and Prevention allowed cruises to return this year with strict safety protocols and requirements in place to prevent outbreaks from occurring onboard.

Carnival has resumed sailing or announced plans to resume sailing 42 ships from eight of the company’s nine cruise brands by the end of November this year.

“We are working aggressively on our path to return our full fleet to operations by next spring. So far, we have announced that 42 ships, representing over half of our capacity, have been scheduled to return to serving guests by this fiscal year end,” Carnival Corporation President and CEO Arnold Donald said in a press release.

Cruise line stocks are slowly rebounding this year after suffering huge losses during the pandemic.

Shares of Carnival fell more than 2% on Thursday. Carnival’s stock has risen 28% this year, putting its market cap at just over $27 billion.

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Rudy Giuliani suspended from practicing law due to Trump statements

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A New York court on Thursday suspended Rudy Giuliani from practicing law in New York state due to making “false and misleading statements” about the election loss of former President Donald Trump, his client.

The suspension, which takes effect immediately, is a stunning blow to Giuliani, the former New York City mayor who previously served as a top Justice Department official and as the U.S. Attorney in Manhattan.

It also comes as Giuliani is under criminal investigation by that same federal prosecutor’s office in Manhattan in connection with his work in Ukraine.

Giuliani and Trump since last November have made false claims about the legitimacy of the election of President Joe Biden, claiming that Trump was swindled out of a victory only by widespread ballot fraud in key swing states.

Giuliani’s suspension, which was ordered a day short of his 52nd anniversary as a licensed lawyer in New York, was sought by the Attorney Grievance Committee for the First Judicial Department, which encompasses Manhattan. The suspension was granted by the Appellate Division for that same department of state Supreme Court.

The court, in its 33-page suspension order, noted that “interim suspension is a serious remedy, available only in situations where it is immediately necessary to protect the public from” an attorney’s violations of the Rules of Professional Conduct.

“We conclude that there is uncontroverted evidence that respondent communicated demonstrably false and misleading statements to courts, lawmakers and the public at large in his capacity as lawyer for former President Donald J. Trump and the Trump campaign in connection with Trump’s failed effort at reelection in 2020,” the order said.

The court also said Giuliani’s “false statements were made to improperly bolster respondent’s narrative that due to widespread voter fraud, victory in the 2020 United States presidential election was stolen from his client.”

“We conclude that respondent’s conduct immediately threatens the public interest and warrants interim suspension from the practice of law, pending further proceedings before the Attorney Grievance Committee.”

One of the examples cited by the order was Giuliani’s repeated claim in an effort to discredit election results that “dead people ‘voted’ in Philadelphia.”

Giuliani at various times claimed that 8,021 dead people’s ballots were cast, “while also reporting the number as 30,000.”

“As the anecdotal poster child to prove this point, he repeatedly stated that famous heavyweight boxer Joe Frazier continued to vote years after he was dead and stated on November 7, 2020 ‘he is still voting here,’ ” the order noted.

In fact, the order added, “The public records submitted on this motion unequivocally show that respondent’s statement is false. Public records show that Pennsylvania formally cancelled Mr. Frazier’s eligibility to vote on February 8, 2012, three months after he died.”
Giuliani’s suspension is temporary, pending the outcome of a full formal disciplinary hearing.

Giuliani’s lawyers John Leventhal and Barry Kamins said in a statement, “We are disappointed with the Appellate Division, First Department’s decision suspending Mayor Giuliani prior to being afforded a hearing on the issues that are alleged.”

“This is unprecedented as we believe that our client does not pose a present danger to the public interest,” the statement said. “We believe that once the issues are fully explored at a hearing Mr. Giuliani will be reinstated as a valued member of the legal profession that he has served so well in his many capacities for so many years.”

New York state Sen. Brad Hoylman, (D-Manhattan, who had filed the formal complaint with the Attorney Grievance Committee, said, “I’m glad” about the suspension.

“The profession of law is a sacred and noble one,” Hoylman said in a statement. “And there can be no room in the profession for those who seek to undermine and undo the rule of law as Rudy Giuliani has so flagrantly done.”

This is breaking news. Check back for updates.

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