FDA panel endorses booster shot of J&J Covid-19 vaccine – latest updates

Friday, October 15, 2021

FDA panel endorses booster shot for J&J Covid-19 vaccine

US health advisers have endorsed a booster of Johnson & Johnson’s Covid-19 vaccine, citing growing worry that Americans who got the single-dose shot aren’t as protected as those given two-dose brands.

Advisers to the Food and Drug Administration weighed J&J’s proposal for a flexible booster schedule. The company said the extra dose adds important protection as early as two months after initial vaccination -- but that it might work better if people wait until six months later.

The FDA’s advisory panel voted unanimously that the booster should be offered at least two months after immunization but didn’t suggest a firm time.

The advisers cited growing evidence that J&J recipients are more vulnerable to infection than people who got vaccines from competitors Pfizer or Moderna— and that most got their single dose many months ago.

Although Friday’s meeting is part of an ongoing evaluation of vaccine boosters, many of the experts said it makes more sense to think of J&J's vaccine as a two-dose vaccine.

Pfizer/BioNTech submit data to EMA for Covid-19 vaccine in young children

Pfizer Inc and German partner BioNTech SE have said that they had submitted data supporting the use of their Covid-19 vaccine in children aged between five and less than 12 years to the European Medicines Agency.

Although the vaccine is currently not allowed for that age group, it has been authorized for use in children over 12 years of age in both the United States and the European Union.

The companies earlier this month asked US regulators to also grant emergency use authorization of the shot for young children, and an advisory panel to the US Food and Drug Administration is expected to meet next month to review the data.

While children are less susceptible to severe Covid-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.

The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in five to 11-year-olds in a 2,268-participant clinical trial, the companies said on September 20. 

Brussels makes Covid-19 pass obligatory in restaurants, gyms

People are obliged to show their Covid-19 passes before entering restaurants, gyms and hospitals in Brussels as of Friday.

An updated act of the Brussels regional parliament entered into force on Friday that requires people over 16 years of age to show their “Covid Safe Ticket” before entering cafes, restaurants, fitness centers, discos, and cultural venues hosting more than 50 participants in the Belgian capital.

Visitors in hospitals and nursing homes must show their passes too, but patients are still allowed to enter the clinics without proof of vaccination or PCR test.

Without a pass, people can only sit on the terraces of bars and restaurants and go to cinemas, theatres, museums, and other cultural events that host less than 50 participants.

The so-called “Covid Safe Ticket” is in reality the same pass that was introduced in the summer to facilitate travel within the EU.

The document is available on smartphone or paper format, featuring a QR code that allows determining the Covid-19 status of the holder.

It proves if a person had received all the recommended doses of vaccine approved by the European Medicine Agency, had a negative PCR test over the past 48 hours or a negative antigen test within 24 hours, or recovered from the illness in the last six months.

Saudi Arabia to ease pandemic curbs from October 17

Saudi Arabia will ease Covid-19 curbs from October 17 in response to a sharp drop in daily infections, State News Agency said quoting an Interior Ministry official.

The government will lift social distancing measures and allow full-capacity attendance at the country's two holy mosques in Mecca and Medina, the agency added.

UK records 145 more Covid-19 deaths

Britain has recorded 145 more deaths from Covid-19, taking the total number of fatalities within 28 days of a positive test to 138,379, official figures showed.

Some 44,932 new positive tests for Covid-19 were reported, down slightly from 45,066 reported on Thursday. The number of new cases in the past seven days rose to 281,042, up more than 11 percent from a week earlier. 

US-Mexico land border reopening set for November 8

The US-Mexico land border reopening to non-essential travel will begin on November 8, Mexican Foreign Minister Marcelo Ebrard said, after more than a year of pandemic-caused restrictions.

Italy reports 42 coronavirus deaths and 2,732 new cases

Italy has reported 42 coronavirus-related deaths on Friday, up from 40 the previous day, the Health Ministry said, while the daily tally of new infections fell to 2,732 from 2,668.

Italy has registered 131,503 deaths linked to Covid-19 since the outbreak in February last year. It has the second highest toll in Europe behind Britain and the ninth highest in the world. The country has reported 4.71 million cases to date.

Patients in hospital with Covid-19 — not including those in intensive care — stood at 2,445 on Friday, down from 2,479 a day earlier.

There were 20 new admissions to intensive care units, decreasing from 22 on Thursday. The total number of patients in intensive care with Covid-19 fell to 357 from a previous 359.

Some 506,043 tests for Covid-19 were carried out in the past day, compared with a previous 324,614, the Health Ministry said. 

Russia reports record daily infections, deaths

Russia has reported a record 999 coronavirus-related deaths in the last 24 hours as well as 32,196 new infections, its highest single-day case tally since the start of the pandemic.

The Kremlin has blamed the rising death toll on Russia's slow vaccination campaign.

South Korea eases virus gathering curbs before switch to 'living with Covid'

South Korea has said it would lift stringent anti-coronavirus curbs on social gatherings next week, as the country prepares to switch to a 'living with Covid-19' strategy amid rising vaccination levels.

A new panel established this week is drawing up a plan for a gradual return to normalcy in the long term, eventually lifting sweeping restrictions and reopening the economy in November on the expectation that 80 percent of the adult population will be fully vaccinated.

From Monday, the government will allow gatherings of up to four unvaccinated people, and ease operating-hour restrictions imposed on venues like restaurants, cafes and cinemas, Prime Minister Kim Boo-kyum told a Covid-19 response meeting.

In the Seoul area, gatherings of up to eight people will be allowed if a group includes four fully vaccinated people, and in other regions, up to 10 people will be allowed to gather.

South Africa to vaccinate teenagers with single dose of Pfizer

South Africa will start vaccinating children between the ages of 12 and 17 next week using the Pfizer vaccine, the health minister said, as the country looks to ratchet up inoculations ahead of final year examinations.

"This service will start on the 20th of October to allow the necessary pr eparations on the EVDS (electronic vaccination data system) registration system and also other logistical preparations," Health Minister Joe Phaahla said.

UK: 1000s may have gotten false negative test results

British health officials said that an estimated 43,000 people may have been wrongly told they don’t have the coronavirus because of problems at a private laboratory.

The UK Health Security Agency said a lab in Wolverhampton, central England, has been suspended from processing test swabs after reports of false negatives. The faulty results were among tests processed at the Immensa Health Clinic Lab between early September and this week.

The issue was uncovered after some people who were positive for Covid-19 when they took rapid tests went on to show up as negative on more accurate PCR tests.

“Around 400,000 samples have been processed through the lab, the vast majority of which will have been negative results, but an estimated 43,000 people may have been given incorrect negative PCR test results," mostly in southwest England, the health agency said.

The agency called the problem “an isolated incident attributed to one laboratory” and said the people affected would be contacted and advised to get another test.

Protests and blockades: Italy braces for new Covid rules

Italy is bracing for nationwide protests, blockades, and potential disruption as tough new coronavirus restrictions for workers came into effect.

All workers must show a so-called Green Pass, offering proof of vaccination, recent recovery from Covid-19, or a negative test -- or face being declared absent without pay.

More than 86 percent of Italians over the age of 12 have received at least one jab, thus automatically qualifying for the certification.

But up to three million workers are estimated to be unvaccinated -- and most will only be able to work if they pay for their own tests either every 48 or 72 hours, depending on the type.

Fourteen US state attorneys general press Facebook on vaccine disinformation

The attorneys general of 14 US states have sent a letter to Facebook Inc Chief Executive Mark Zuckerberg asking if the top disseminators of vaccine disinformation on the platform received special treatment from the company.

The line of inquiry was generated after Facebook whistleblower Frances Haugen used internal documents to disclose that the social media platform has built a system that exempts high-profile users from some or all of its rules.

In the letter, which was sent on Wednesday, the 14 Democratic attorneys general said they are "extremely concerned" with recent reports that Facebook maintained lists of members who have received special treatment, and want to know if the "Disinformation Dozen" were part of those lists.

The Center for Countering Digital Hate describes the "Disinformation Dozen" as 12 anti-vaxxers who are responsible for almost two-thirds of anti-vaccine content circulating on social media platforms.

Sydney to end quarantine for international travellers

Sydney will end its quarantine for fully vaccinated international travellers from November 1, New South Wales Premier Dominic Perrottet said on Friday, foreshadowing the full return of overseas travel after more than 19 months.

Australia closed its international borders in March 2020 in response to the pandemic, allowing entry almost exclusively to only citizens and permanent residents who are required to undergo a mandatory two-week hotel quarantine at their own expense.

"We want people back, we are leading the nation out of the pandemic ... we are opening Sydney and New South Wales to the world," Perrottet told reporters in Sydney, the state capital.

The federal government's reopening plans unveiled in July proposed abolishing caps on returning vaccinated Australians and a gradual reopening of international travel with safe countries once full vaccination rates reach 80 percent.

Infections linger near record levels in Australia's Victoria

Covid cases in Australia's Victoria hovered near record levels, even as authorities look set to lift lockdown restrictions next week in Melbourne, the state capital, as the state nears a key vaccination milestone.

A total of 2,179 new locally acquired cases were reported in Victoria, the majority in Melbourne, down from a record 2,297 a day earlier. State Premier Daniel Andrews has said some curbs will ease next week as Victoria's double-dose vaccination levels race towards the 70 percent mark from 63 percent now.

Australia had stayed largely virus-free for most of this year until the third wave of infections fuelled by the fast-moving Delta variant spread across its southeast from late June, forcing a months-long lockdown in Sydney, Melbourne, and Canberra.