US FDA clears Moderna, J&J COVID-19 boosters, backs use of different vaccine for boost

The panel also recommended a second shot of the J&J vaccine for all recipients of the one-dose inoculation at least two months after receiving their first. (AFP)
Short Url
Updated 21 October 2021

US FDA clears Moderna, J&J COVID-19 boosters, backs use of different vaccine for boost

The US Food and Drug Administration on Wednesday authorized booster doses of the COVID-19 vaccines from Moderna Inc. and Johnson & Johnson, and said Americans can choose a different shot from their original inoculation as a booster.
That means all three vaccines authorized in the United States can also be given as boosters to some groups.
“The availability of these authorized boosters is important for continued protection against COVID-19 disease,” acting FDA Commissioner Janet Woodcock said in a statement. She noted that data suggests vaccine effectiveness may wane over time in some fully vaccinated people.
The decision paves the way for millions in the United States to get the additional protection as the highly contagious Delta variant of the virus causes breakthrough infections among some who are fully vaccinated.
The agency previously authorized boosters of the Pfizer Inc. COVID-19 vaccine developed with German partner BioNTech SE at least six months after the first round of shots to increase protection for people aged 65 and older, those at risk of severe disease and those who are exposed to the virus through their work.
Last week, an advisory panel to the FDA voted to recommend a third round of shots of the Moderna vaccine for the same groups. Moderna’s booster is half the strength of the shots administered for the company’s initial series of inoculations.
The panel also recommended a second shot of the J&J vaccine for all recipients of the one-dose inoculation at least two months after receiving their first.
FDA officials suggested last week they were considering lowering the recommended age for booster shots of the Pfizer/BioNTech vaccine to as young as 40, based on data from Israel, where Pfizer booster shots have already been administered broadly.
They did not lower the age range for the shots on Wednesday, but said they were assessing the benefits and risks of broader use of boosters and plan to update the public in the coming weeks.
“There is evidence that suggests potentially that lowering the age of those eligible for boosters may make sense in the future,” FDA official Peter Marks told a news conference. “It’s something we’re looking at closely.”
The FDA and US Centers for Disease Control and Prevention (CDC) were under pressure to authorize the additional shots after the White House announced plans in August for a widespread booster campaign.
The advisory panel meeting included a presentation of data on mixing vaccines from a US National Institutes of Health study in which 458 participants received some combination of Pfizer/BioNTech, Moderna and J&J shots.
The data showed that people who initially got J&J’s COVID-19 vaccine had a stronger immune response when boosted with either the Pfizer or Moderna shot, and that “mixing and matching” booster shots of different types was safe in adults.
Still, FDA officials said the data was not yet clear on whether any shot combination should be preferred.
“Because we don’t have those data right now, I think we just have to be noncommittal about what is the best,” Marks said.
Many countries including the UK have backed mix-and-match strategies for the widely used AstraZeneca Plc vaccine, which is not authorized in the United States but is based on similar viral vector technology as J&J’s vaccine.
Reuters reported in June that infectious disease experts were weighing the need for booster shots of either the Pfizer or Moderna vaccine after the J&J shot.
A CDC advisory committee on Thursday will make its recommendations about which groups of people should get the Moderna and J&J boosters, which the agency’s director will use to inform her final decision.
About 11.2 million people have so far received a booster dose, according to data from the CDC.
 


Malaysia detects first omicron case in quarantined traveler from South Africa

Updated 58 min 22 sec ago

Malaysia detects first omicron case in quarantined traveler from South Africa

  • The 19-year-old woman was asymptomatic and had been vaccinated
  • Five other people who shared a vehicle with her prior to her quarantine all tested negative

KUALA LUMPUR: Malaysia has detected its first case of the omicron coronavirus variant in a foreign student who was quarantined after arrival from South Africa two weeks ago, its health minister said on Friday.
Authorities had re-tested earlier positive samples after the World Health Organization (WHO) announced omicron as a variant of concern on Nov. 24, minister Khairy Jamaluddin said.
The 19-year-old woman, who was asymptomatic and had been vaccinated, had tested positive for COVID-19 on arrival in Malaysia, via Singapore, and was quarantined for 10 days before being released on Nov. 29, Khairy said.
Five other people who shared a vehicle with her prior to her quarantine all tested negative.
Authorities, however, have asked the student along with eight close contacts to undergo further testing after her earlier test samples were confirmed to be the new variant, Khairy added.
An increasing number of countries are reporting cases of the omicron variant, which the WHO has said carries a very high risk of causing surges of infection.
Neighbouring Singapore confirmed two imported cases on Thursday.
This week, Malaysia temporarily banned the entry of travelers from eight southern African countries that have reported the presence of the variant or are considered high-risk.
On Friday, Khairy said Malaysia would immediately imposed further restrictions, including additional tests for vaccinated travelers from Singapore, who are allowed to enter Malaysia without quarantine.


Attacker dressed like ninja wounds two French policewomen with sword – police

Updated 03 December 2021

Attacker dressed like ninja wounds two French policewomen with sword – police

  • A police spokeswoman said there were no immediate signs that the attack was terrorism-related

PARIS: A man dressed like a ninja attacked and wounded two policewomen with a sword in Cherbourg in northwestern France on Thursday before being shot and captured, a police spokeswoman said.
She said there were no immediate signs that the attack was terrorism-related.
She said the attacker had stolen a vehicle and caused an accident, after which he assaulted two policewomen who had been called to the scene, wounding one in the face and the other in the chin.
The assailant — dressed in black in the style of traditional Japanese ninja fighters — was shot three times by the officers and was flown to hospital by helicopter in serious condition.
The attack happened around 3:45 p.m. (1445 GMT) near a gas station of the Leclerc supermarket chain.
The name and nationality of the attacker were not immediately known.


Germany backs restrictions for unvaccinated as mandate looms

Updated 02 December 2021

Germany backs restrictions for unvaccinated as mandate looms

  • Measures were necessary in light of concerns that hospitals in Germany could become overloaded
  • “The situation in our country is serious,” Merkel told reporters in Berlin, calling the measure an “act of national solidarity”

BERLIN: German Chancellor Angela Merkel said Thursday that people who aren’t vaccinated will be excluded from nonessential stores, cultural and recreational venues.
And parliament will consider a general vaccine mandate as part of efforts to curb coronavirus infections that again topped 70,000 newly confirmed cases in a 24-hour period.
Speaking after a meeting with federal and state leaders, Merkel said the measures were necessary in light of concerns that hospitals in Germany could become overloaded with people suffering COVID-19 infections, which are more likely to be serious in those who haven’t been vaccinated.
“The situation in our country is serious,” Merkel told reporters in Berlin, calling the measure an “act of national solidarity.”
She said officials also agreed to require masks in schools, impose new limits on private meetings and aim for 30 million vaccinations by the end of the year — an effort that will be boosted by allowing dentists and pharmacists to administer the shots.
Merkel herself backed the most contentious proposal of imposing a general vaccine mandate. She said parliament would debate the proposal with input from the country’s national ethics committee.
If passed, it could take effect as early as February, Merkel said, adding that she would have voted in favor of the measure if she were still a member of parliament.
About 68.7 percent of the population in Germany is fully vaccinated, far below the minimum of 75 percent the government is aiming for.
There have been large protests against pandemic measures in the past in Germany and the vaccine mandate is likely to be opposed by a minority, though opinion polls show most Germans are in favor.
Finance Minister Olaf Scholz, who is expected to be elected chancellor by a center-left coalition next week, has also backed a general vaccine mandate, but favors letting lawmakers vote on the issue according to their personal conscience rather than party lines.
“If we had a higher vaccination rate, we wouldn’t be discussing this now,”he said.
The rise in COVID-19 cases over the past several weeks and the arrival of the new omicron variant have prompted warnings from scientists and doctors that medical services in the country could become overstretched in the coming weeks unless drastic action is taken. Some hospitals in the south and east of the country have already transferred patients to other parts of Germany because of a shortage of intensive care beds.
Agreeing what measures to take has been complicated by Germany’s political structure — with the 16 states responsible for many of the regulations — and the ongoing transition at the federal level.
Germany’s disease control agency reported 73,209 newly confirmed cases Thursday. The Robert Koch Institute also reported 388 new deaths from COVID-19, taking the total since the start of the pandemic to 102,178.
To reduce the pressure on hospitals over the festive period, the sale of fireworks traditionally set off during New Year’s in Germany will be banned. Each year, hospitals treat hundreds of people with serious injuries because of mishandled fireworks.
The new measures will take effect once Germany’s 16 states incorporate them into existing rules, likely in the coming days.


Norway reports large outbreak of omicron variant infections

Updated 02 December 2021

Norway reports large outbreak of omicron variant infections

  • “More cases are expected. Effective tracing is being done to limit transmission routes and prevent major outbreaks,” said Oslo Municipality
  • The government agency said that there was “a high vaccination coverage” in the group

COPENHAGEN: At least 50 people in and around Norway’s capital have been infected with the omicron coronavirus variant and the cases are connected to a Norwegian company’s Christmas party in an Oslo restaurant, officials said Thursday.
“More cases are expected. Effective tracing is being done to limit transmission routes and prevent major outbreaks,” the Oslo Municipality said in a statement.
The Norwegian Institute of Public Health said that those affected live in Oslo and surrounding municipalities, and “the infection detection team in Oslo has contacted the municipalities concerned to start infection detection.”
The government agency said that there was “a high vaccination coverage” in the group, adding that overall “more than 50 cases” have been recorded in Norway. The country’s first two cases were announced Monday.
On Wednesday the city of Oslo urged people who visited two restaurants in the capital to be tested. One reportedly was where the Christmas party was held.
Much remains unknown about the new variant, including whether it is more contagious, as some health authorities suspect, whether it makes people more seriously ill, and whether it can thwart vaccines.
It is customary in Scandinavia for companies, associations and individuals to hold Christmas parties in the weeks leading up to Christmas eve.


Pope Francis arrives in Cyprus with migrants in focus

Updated 02 December 2021

Pope Francis arrives in Cyprus with migrants in focus

  • On Friday he is scheduled to perform mass at an open-air stadium and later hold an 'ecumenical prayer' with migrants at a Catholic Church
  • Francis has arranged to have 50 migrants relocated to Italy after his trip this week

LARNACA, Cyprus: Pope Francis arrived on Cyprus on Thursday with a focus on inter-faith dialogue and lending his support to a country on one of the frontlines of Europe’s migration crisis.
Francis, who will travel on to Greece on Dec. 4, was to meet with Cyprus’s president on Thursday as well as with the Maronite Church. On Friday he is scheduled to perform mass at an open-air stadium and later hold an ‘ecumenical prayer’ with migrants at a Catholic Church in the divided capital.
“It will be a beautiful trip but we will touch some wounds. I hope that we all will be able to gather up the messages given to us,” Pope Francis told journalists on the aircraft.
Young children waving flags of Cyprus and the Vatican welcomed Francis at Larnaca airport, and three young girls in Cypriot traditional dress gave him bouquets of flowers.
Cyprus says it is struggling to cope with an influx of undocumented migrants, either through a dividing line splitting the island, or by boats from the neighboring Middle East.
Francis, who has made defense of migrants and refugees a cornerstone of his papacy, has arranged to have 50 migrants relocated to Italy after his trip this week.
Francis’s predecessor, Pope Benedict, visited Cyprus in 2010. Cyprus’s Orthodox Church, the dominant Christian communion, traces its lineage back to some of Christ’s earliest followers.
According to the Book of Acts in Christian scripture, St. Paul visited the island with Barnabas, the founder of Cyprus’s Church, and Mark the Evangelist.
The Pope will be staying at a Franciscan monastery in the capital Nicosia, one of the last divided capitals of the world. The Roman Catholic Holy Cross Church, in the same compound, still bears scars from the crossfire of ethnic strife and from a Turkish invasion triggered by a Greek-inspired coup in 1974.