The Latest: Johnson & Johnson pauses virus vaccine study
NEW BRUNSWICK, N.J. — Johnson & Johnson executives say it will be a few days before they know more about an unexplained illness in one participant that caused a temporary pause in its late-stage COVID-19 vaccine study.
“It may have nothing to do with the vaccine,” Mathai Mammen, head of research and development for Janssen, Johnson & Johnson’s medicine development business, said Tuesday.
Mammen says they don’t yet know whether the ill study participant received their experimental vaccine or a dummy shot. He says Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires. It will recommend next steps.
The study of the one-dose vaccine called ENSEMBLE will include up to 60,000 people from multiple countries. The company expects to complete enrollment in the study in two or three months.
Johnson & Johnson isn’t disclosing the nature of the illness, which it learned of Sunday and disclosed Monday night. Such pauses are not uncommon in long clinical studies, as some participants come down with an unrelated illness.
Unlike a study hold imposed by government regulators, a pause is initiated by the sponsor of the drug trial and often can be quickly resolved.
HERE’S WHAT YOU NEED TO KNOW ABOUT THE VIRUS OUTBREAK:
— WHO: Europe reported more than 700,000 coronavirus cases last week
— India has 55,342 coronavirus cases, lowest single-day tally since mid-August
— Israel surpasses 2,000 deaths from coronavirus
— A safety monitoring panel will try to determine what might have caused sickness in a second COVID-19 vaccine trial paused over unexplained illness
— China city says it’s tested 3 million for coronavirus, following the country’s first reported local outbreak in nearly two months.
— Giro d’Italia cycling race uncertain after two full teams and two elite riders withdraw following a series of positive tests for the coronavirus.
— Follow AP’s pandemic coverage at http://apnews.com/VirusOutbreak and https://apnews.com/UnderstandingtheOutbreak
HERE’S WHAT ELSE IS HAPPENING:
ROME — Italian Premier Giuseppe Conte says the aim of Italy’s new anti-virus restrictions limiting nightlife and socializing is to head off another general lockdown.
Conte defended the measures as both “adequate and proportional.” He spoke Tuesday as the health ministry reported another 5,901 people tested positive in the past day and 41 deaths.
That brings Italy’s official COVID-19 death toll to 36,246, the second highest in Europe after Britain.
Conte on Tuesday issued a new decree requiring bars and restaurants to close at midnight and preventing consumption of alcohol and food outside bars after 9 p.m. The measures, as well as recommended limits on private parties, aim to decrease casual socializing blamed for Italy’s latest surge.
Currently, Italy has more than 5,000 people in the hospital and 500 in intensive care, a fraction of the springtime peak, but worrisome given cases are surging in every Italian region.
SARAJEVO, Bosnia-Herzegovina — People are lining up in Bosnia’s capital of Sarajevo waiting for tests on the coronavirus amid a new surge.
The pressure is rising on the health system in Bosnia, which is one of the poorest countries in Europe after going through a devastating war during the 1990s.
Doctors say the numbers of infected have been on the rise, with people flocking to the medical clinics also due to seasonal respiratory diseases and the flu.
Bosnia has reported 926 confirmed deaths from the coronavirus in a country of 3.3 million.
BERLIN — Germany’s domestic intelligence agency says its chief has tested positive for coronavirus and will continue to work while quarantined at home.
The BfV says Thomas Haldenwang, who has headed the agency for about two years, had tested positive on Monday for the virus.
The agency wouldn’t say who Haldenwang had come into contact with before learning he was positive.
The agency says it established a crisis team early in the pandemic to ensure its ability to keep working.
BIRMINGHAM, Ala. — The Vanderbilt at Missouri football game is the first Southeastern Conference game postponed by the coronavirus.
The game scheduled for Saturday has been postponed because coronavirus issues have left the Commodores without enough players. The SEC announced the game has been tentatively rescheduled for Dec. 12.
Vanderbilt says it couldn’t reach the SEC’s 53-player minimum this week “due to the quarantining of individuals with positive tests and those designated as close contacts, along with injuries and opt-outs.”
It is the 28th FBS game overall to be postponed or canceled since Aug. 26. The SEC started Sept. 26, a few weeks later than the rest of the FBS conferences that began play in September.
WARSAW, Poland — Poland’s Prime Minister Mateusz Morawiecki says he’ll quarantine after he met last week with a person who tested positive for the coronavirus.
In a video message, Morawiecki says his government was working as usual. He urged the citizens to observe social distancing, wear masks and disinfect hands.
A nation of 38 million, Poland has had a sharp spike in new registered case of coronavirus infections, with 5,068 cases reported Tuesday and 63 deaths.
In the summer, the new daily cases were around 600. But the numbers started rising quickly after vacation. Some doctors say the chronically underfunded health care system may give in if the current rate of new cases continues.
Overall, there have been 135,000 confirmed cases and more than 3,100 deaths in Poland.
DUBAI, United Arab Emirates — The United Arab Emirates has recorded 1,315 new coronavirus cases, its biggest single-day infections since the start of the pandemic.
The numbers on Tuesday bring the total in the country to more than 108,600 cases and 448 deaths.
Recorded infections have soared again in recent weeks as authorities relaxed restrictions and schools resumed in-person instruction. Dubai, the region’s business hub, recently reopened its airport for international travelers.
Although coming amid an aggressive testing campaign, the upward trend has raised concerns there could be lockdowns in parts of the country that rely heavily on tourism.
GENEVA — The World Health Organization said European nations reported more than 700,000 new coronavirus cases last week — the highest figure since the start of the pandemic.
In a weekly briefing published Tuesday, WHO said weekly virus cases and deaths across Europe jumped by 34% and 16% respectively. Britain, France, Russia and Spain accounted for more than half of the new cases seen in the region.
WHO noted that the number of new cases reported in Spain showed a “noticeable decline” in comparison to recent weeks. But in Poland, WHO said virus cases and deaths spiked by 93% and 104% respectively, and the government has tightened restrictions to try avoiding another lockdown.
WHO Director-General Tedros Adhanom Ghebreyesus said this week that the agency understood the frustration people were feeling as the pandemic drags on but warned “there are no shortcuts and no silver bullets.”
WHO described lockdowns a “last resort” when countries have no other options and urged officials to use more targeted methods to stop the virus.
COPENHAGEN, Denmark — The government in Norway says it will make the vaccine free and will cover the costs that municipalities and hospitals may have in connection with vaccinations.
Health Minister Bent Hoeie says the government’s decision was based on recommendation by the Norwegian Institute of Public Health. That agency will also be preparing a national vaccination plan with a priority order.
“We hope to be able to start offering vaccines as early as 2021 but the time for start-up will depend on when pharmaceutical authorities give their approval,” Hoeie told the Norwegian parliament.
Norway has seen 15,524 coronavirus cases and 276 deaths.
TAIPEI, Taiwan — Taiwan says it has disagnosed coronavirus in a Taiwanese citizen returning from China for the first time since February.
The patient, identified only as a man in his forties, reported having a runny nose and cough to quarantine officials upon his arrival in Taiwan on Sunday, spokesperson for the Central Epidemic Command Center Chuang Jen-hsiang told reporters Tuesday.
Chuang said the man had been working in the eastern province of Jiangsu, which, according to China’s National Health Commission, has not reported any recent cases of local transmission.
He said Taiwan’s last case of a person bringing the virus from China was on February 6.
China administers routine temperature checks at its airports. However, Chuang was not required to submit a negative virus test on returning to Taiwan, Chiang said.
Taiwan took strong measures to arrest the spread of COVID-19 but has since relaxed many of those measures. The island has reported 530 cases with seven virus-related deaths.
LONDON — Britain’s government defended its new three-tier system of COVID-19 restrictions as critics suggested it was too little, too late amid reports the government’s scientific advisers recommended tougher action three weeks ago.
Prime Minister Boris Johnson unveiled the new system Monday in a carefully orchestrated series of events that culminated with an address to the nation. The plan sets out progressively stricter measures to slow the spread of COVID-19 based on local infection rates and placed the northern city of Liverpool in the highest risk category.
The new system comes three weeks after the government’s last nationwide program, which banned gatherings of more than six people and required pubs and restaurants to close at 10 p.m. The government’s scientific advisers at that time recommended ministers go further, suggesting a two- to three-week national lockdown to short-circuit rapidly rising infection rates.
Communities Secretary Robert Jenrick told the BBC that the government took “robust action” in response to the scientist’s advice, but ministers had to balance this against other impacts like the economy.
ROME — Italian Premiere Giuseppe Conte has ordered strict new anti-coronavirus measures, including limits on private gatherings and a ban on casual pickup sports.
Conte negotiated with the country’s regions to win limits on private gatherings, over the objections of some governors. Parties in closed spaces are banned, but the measures, imposed Tuesday, are limited to “strong recommendations” against private gatherings in homes with more than six people who don’t live under the same roof.
Bars and restaurants must close by midnight, and drinks can only be consumed at tables — not while standing at the bar or outside — after 9 p.m. Also banned are any contact sports that are not organized by an association that can maintain distancing rules. That means no casual games of Italy’s beloved soccer in local parks.
After mandating the wearing of masks outdoors last week, the government sought the additional measures, with the number of new cases rising to around 5,000 a day in the past week.
JERUSALEM — Israel has now recorded more than 2,000 deaths from the coronavirus as the country remains under lockdown for a fourth week to quell the outbreak.
The Health Ministry reported Monday night that the country had surpassed 2,000 deaths. It reported five more fatalities on Tuesday, raising the toll to 2,021.
Israel — which has confirmed more than 295,000 cases — had garnered praise earlier this year for its swift imposition of travel restrictions to limit the pandemic’s spread, but after lifting the first nationwide lockdown in May, new cases quickly increased.
Prime Minister Benjamin Netanyahu’s government imposed a second blanket lockdown on Sept. 18 as the infection rate per capita grew to one of the highest in the world.
Israel’s infection rate is gradually decreasing, and the Cabinet is deliberating how and when the government will start to lift restrictions.
ISLAMABAD — With Pakistan’s coronavirus caseload inching upward, the government has increased lockdowns across the country, targeting markets and neighborhoods with increasing numbers.
At a meeting of top government officials from across the country Tuesday, Planning and Development Minister Asad Umar said 3,497 so-called “smart” lockdowns have been imposed in districts across the country of 220 million people.
Pakistan has recorded 319,848 cases, including 531 new ones reported Tuesday.
NEW DELHI — India has registered 55,342 new coronavirus cases, its lowest single-day tally since mid-August.
The Health Ministry raised India’s confirmed total to more than 7.17 million cases on Tuesday but said the country was showing a trend of declining daily cases over the last five weeks.
The ministry also reported 706 deaths in the past 24 hours, raising the toll to 109,856.
According to data shared by the Health Ministry, the average number of daily cases from Sept. 9-15 was 92,830. The average has steadily declined since then, falling to under 73,000 per day over the last week.
Meanwhile, India’s testing rate has remained constant, with almost 1.1. million tests being carried out every day.
India, a country of nearly 1.4 billion people, is second in the world in total cases, behind only the U.S., which has confirmed over 7.8 million infections.