(Bloomberg) — U.S. regulators added a warning to Johnson & Johnson’s vaccine after a rare immune-system disorder was reported in about 100 of the more than 12 million people who received the inoculation. The Food and Drug administration said the data was insufficient to be able to say definitively the shot had caused the Guillain-Barré syndrome.
The development came after the U.S. recorded its biggest weekly increase in Covid infections since April 2020. Cases soared 47% for the week ending Sunday, as the delta variant spreads while vaccination rates fall.
Elsewhere, the United Nations reported that world hunger spiked last year, outpacing population growth and probably reaching the highest since 2005, as the pandemic curbed incomes and access to food. In Europe, both France and Greece are planning to mandate shots for at least some of their citizens, while U.K. Prime Minister Boris Johnson is set to warn people to stay vigilant as he prepares to lift virtually all remaining curbs in England. Science advisers are concerned.
J&J Shot Gets Warning About Rare Disorder (5:37 a.m. HK)
The fact sheet for Johnson & Johnson’s Covid-19 vaccine was revised to warn of the risk of a rare immune-system disorder, adding new headwinds for a shot once expected to be a linchpin of the U.S. immunization effort.
The Food and Drug Administration said in a statement Monday that it was adding the warning after 100 reports of Guillain-Barré Syndrome, a rare condition in which the immune system attacks the nerves, among people who had received the shot. So far, about 12.8 million Americans have been given the one-dose vaccine.
The agency said that 95 of the cases required hospitalization and that one person had died. While the available evidence suggests a link between the shot and the syndrome, the agency said that the data was insufficient to be able to say definitively it had caused the illness.
Fire at Iraqi Hospital Kills 36 Covid Patients (4:43 p.m. NY)
A fire at the al-Hussein hospital in the southern Iraqi city of Nassiriya killed at least 36 Covid-19 patients and injured dozens, according to the state-run Iraqi News Agency.
Warren Seeks Amazon Mask Probe (3:31 p.m. NY)
Senator Elizabeth Warren is urging the Department of Justice and the Federal Trade Commission to review her investigation of Amazon Inc. for deceiving search results on the sale of masks authorized by the U.S, Food and Drug Administration.
Finding the masks on Amazon “is a mess, and Amazon seems to be actively misleading customers,” she says on Twitter.
France to Mandate Shots for Some (3:29 p.m. NY)
France is set to make vaccines compulsory for health-care workers and those who work with vulnerable people, as President Emmanuel Macron tries to encourage the vaccine-shy French to get immunized.
While European countries are on the whole pushing ahead with plans to reopen, they are also looking at new pandemic measures as the rate of infection rises. Macron said he will also force people to use so-called health passes to visit bars and restaurants and step up border controls.
Meanwhile, the Spanish region of Catalonia will force restaurants and nightclubs to close at half-past midnight and limit meetings to 10 people, El Pais newspaper reported.
J&J Tie to Syndrome Weighed (1:42 p.m. NY)
U.S. health officials are monitoring reports of a rare immune-system disorder in some people who received the Johnson & Johnson coronavirus vaccine.
The adverse-event data indicate a “small possible risk” of Guillain-Barré Syndrome, a rare condition in which the immune system attacks the nerves, the Centers for Disease Control and Prevention said in a statement on Monday.
There were 100 preliminary reports of the syndrome out of some 12.8 million doses of the vaccine administered, the CDC said. The cases were seen mostly in men over the age of 50, about two weeks after receiving the single-dose vaccine.The agency noted that the risk of severe adverse events from vaccines remains rare, and that everyone 12 years and older is recommended to receive a vaccine.
The issue will be discussed at an upcoming vaccine advisory committee meeting, the CDC reported.
Unrest Slows South Africa Inoculations (1:30 p.m. NY)
South Africa’s vaccination program faltered amid widespread unrest and looting following the imprisonment of former President Jacob Zuma.
The country vaccinated 146,577 people in the 24 hours to 5 p.m. local time compared with over 191,000 late last week, according to information on a National Department of Health website.
Inoculation numbers had been climbing steadily toward a target of 300,000 a day set by President Cyril Ramaphosa. There were reports of some sites not operating on Monday while many people kept off the streets amid the violence.
Greece Mandates Vaccinations (12:23 p.m. NY)
Greece is mandating vaccinations for those who work in senior citizen homes, within private or public health-care and for those in the military, Prime Minister Kyriakos Mitsotakis said Monday in a national television address.
Meanwhile, all indoor areas — including nightclubs and bars, cinemas and theaters — will only be open for those who have been vaccinated, Mitsotakis said. Greece has seen a jump in the daily number of new coronavirus cases attributed mainly to large social gatherings of younger adults.
U.K. Risks Seen With Curbs Lifted (12:02 p.m. NY)
England is facing multiple “major risks” after pandemic restrictions are lifted next week — including hospitals coming under intense pressure, a new vaccine-resistant variant emerging, and as many as 200 Covid-19 deaths per day.
Newly released data from the U.K.’s Scientific Advisory Group for Emergencies (SAGE) suggests the picture could be far worse if the public immediately abandons basic precautions such as wearing face coverings on trains and in crowded indoor spaces when the rules are eased on July 19.
The findings, based on a clutch of studies commissioned by the government advisory group, will fuel the debate over whether Prime Minister Boris Johnson is taking too big a gamble by pressing ahead with his plan to lift curbs next Monday.
U.S. Cases Soar (11:45 a.m. NY)
Confirmed cases of Covid-19 in the U.S. soared 47% to 136,351 in the week ended Sunday, data compiled by Johns Hopkins University and Bloomberg show. The largest weekly rise since April 2020 comes as the highly contagious delta variant spreads in the country amid declining vaccination rates. The death toll for the period ticked up to 1,629.
While last week’s figures are a fraction of the weekly numbers during the winter, about half of Americans remain unvaccinated, slowing the battle against the virus. The U.S. has administered 334 million doses of vaccine, enough to cover about 52% of residents, according to the Bloomberg Vaccine Tracker.
Globally, cases were up 12% to about 3 million last week, with fatalities at 53,576.
Pfizer Meeting Regulators on Booster (11:30 a.m. NY)
Pfizer Inc. said it is meeting with U.S. health officials Monday to discuss its plans to request an emergency authorization for a third booster dose of its Covid-19 vaccine.
The drugmaker announced Thursday it would seek clearance in August for the booster dose it developed with BioNTech SE on the basis of compelling early data demonstrating it can sharply increase immune protection against the virus. Within hours, federal health officials released a statement suggesting they’d take a cautious approach to potential booster shots, and would not rely on data exclusively from pharmaceutical companies.
The Biden administration declined to comment on the Monday meeting of Pfizer executives and U.S. health officials.
Sputnik Vaccine Is Effective Against Variants (9:02 a.m. NY)
Sputnik V was shown to be effective against new Covid-19 variants, including the alpha, beta, gamma and delta strains, as well as two mutations detected in Moscow, according to a study published in Vaccines magazine.
Pandemic Sparks Worst Hunger Since 2005: UN (9 a.m. NY)
As many as 811 million people — more than a 10th of the global population — were undernourished in 2020, the UN said in a report on Monday. The agency said it will now take a “tremendous” effort for the world to fulfill a pledge to end hunger by 2030, and reiterated a call to transform food systems.
The fallout from the pandemic put healthy food further out of reach for many people, and this year’s surge in food prices to the highest in almost a decade is particularly bad news for poorer countries dependent on imports. Conflict, climate change and economic downturns — the major drivers of food insecurity and malnutrition — continue to increase in both frequency and intensity, and are occurring more often in combination.
U.S. Ships J&J Vaccines to Nepal (8:42 a.m. NY)
The U.S. is delivering more than 1.5 million doses of the Johnson & Johnson’s vaccine to Nepal, Secretary of State Antony Blinken said in on Twitter.
Zimbabwe Speeds Up Vaccinations (8:27 a.m. NY)
Zimbabwe ramped up daily Covid-19 vaccinations to a record as the government expects a faster rollout to help the economy recover from its second contraction into two years.
On Thursday 29,750 people were vaccinated, the highest number since the public rollout plan began earlier this year. To date, 895,980 people have received their first dose and 595,417 a second, according to Ministry of Health data.
Israel Clears Way for Third Pfizer-BioNTech Dose (7:13 a.m. NY)
Israel’s Health Ministry granted permission to health providers to offer a third dose of the Pfizer Inc.-BioNTech SE coronavirus vaccine to immunocompromised patients, Channel 12 news reported Monday.
Patients eligible for the third dose include people who have undergone liver transplants and cancer patients receiving chemotherapy, the report said.