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US health advisers endorse booster shot for J&J Covid-19 vaccine

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

 

J&J told the Food and Drug Administration that an 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.

 

Unable to settle the best timing, the FDA’s advisory panel voted unanimously that the booster should be offered at least two months after people got their earlier shot.

 

“I think this frankly was always a two-dose vaccine;” said FDA adviser Dr. Paul Offit of Children’s Hospital of Philadelphia. “It would be hard to recommend this as a single-dose vaccine at this point.”

 

The FDA isn’t bound by the recommendation as it makes a final decision — and adding to the debate’s complexity; new research also suggests that J&J recipients might have a stronger immune response if their booster dose is from a competing brand.

 

Preliminary results from an ongoing study of different ways to “mix and match” different shots showed that a booster of any sort revved up people’s levels of virus-fighting antibodies; — at least for a few weeks. And the most dramatic jump came from giving a Pfizer or Moderna shot after the single-dose J&J vaccination.

 

FDA’s advisers didn’t vote on whether that should be recommended but told the government to allow flexibility with boosters; saying there were no safety red flags even if it’s not yet clear just how much difference, if any, mixing and matching may make in long-term protection.

 

ALSO READ: FDA advisory panel greenlights Moderna Covid-19 boosters for elderly and at-risk Americans

 

“In the real world all these kind of combinations are already happening so I think it’s a matter of some urgency for the FDA to help sort out what is admittedly a complicated and challenging scenario,” said Dr. Ofer Levy of Boston Children’s Hospital.

 

 

The government says all three US vaccines continue to offer strong protection against hospitalization and death from Covid-19, and that the priority is getting first shots to the 66 million eligible but unvaccinated Americans who are most at risk. But with the spread of the extra-contagious delta variant and signs of waning immunity against milder infections; the nation is moving toward a broader booster campaign.

 

Last month Pfizer boosters started being offered to seniors and younger adults at high risk from Covid-19 because of poor health; jobs or living conditions — at least six months after their initial vaccination.

 

Thursday, the FDA advisory panel recommended the same approach for half-dose Moderna boosters.

 

But J&J’s vaccine has consistently shown lower effectiveness levels across a series of studies — and the FDA panel ultimately settled on another shot for any recipient 18; or older at least two months after their first vaccination.

 

“This is really — with the second dose — bringing it, I think; on par with those other vaccines in terms of effectiveness;” said Dr. Archana Chatterjee of Rosalind Franklin University.

 

The FDA will use its advisers’ recommendations to decide whether to authorize boosters for both J&J and Moderna. Next; the Centers for Disease Control and Prevention would rule on who should roll up their sleeves.

 

The vast majority of the 188 million Americans who are fully vaccinated against Covid-19 have received the Pfizer or Moderna options; while J&J recipients account for only about 15 million.

 

J&J’s vaccine is made with a different technology and on Friday; the company pitched its booster as a way to strengthen a robust vaccine that they said has retained its protective power over eight months. But FDA scientists pointedly challenged that assertion.

 

ALSO READ: EU drug regulator finds possible link between Johnson & Johnson Covid vaccine, rare deep-vein blood clotting cases

“There are data that suggest the effectiveness of this vaccine is actually less robust than the company’s presentation here;” said Dr. Peter Marks, FDA’s top vaccines official. “And that is a finding of concern particularly because that’s been seen in minority communities potentially and others.”

 

As for its booster, J&J presented results from a large study; that found giving a second dose just two months after the first bumped protection against symptomatic Covid-19 to 94 per cent from 70 per cent in US recipients.

 

Giving that booster six months later instead prompted an even bigger jump in virus-fighting antibodies.

 

But in their own review, FDA scientists noted only a tiny portion of cases involved the delta variant; by far the dominant strain in the U.S. And while FDA’s reviewers found no new safety concerns about a second J&J dose, they noted other shortcomings.

 

J&J followed booster recipients for little more than a month, making it hard to draw conclusions about the durability of protection.

 

Also, FDA scientists stressed they hadn’t had time to independently confirm J&J’s data; which were submitted shortly before the meeting. That’s highly unusual and drew serious concern from the advisory panel.

 

The J&J vaccine was highly anticipated for its one-and-done formulation. But its rollout earlier this year was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome.

 

In both cases, regulators decided the shot’s benefits outweighed those risks.

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Grim toll of Covid-19 mounts as SA is set to breach 90,000 deaths soon

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The Paradise Breaking News

The human cost of Covid-19 is mounting, with SA set to soon breach 90,000 deaths.

This as another fatality was reported by the health department on Sunday, bringing the cumulative total to 89,966 since the pandemic reached SA in March last year.

The first coronavirus-related fatality in the country was recorded on March 27 2020, when a 48-year-old woman from the Western Cape succumbed to the coronavirus.

Within days, the death toll had climbed to five and by the end of April last year, 103 South Africans had died, among them casualties of the country’s first outbreak at Durban’s St Augustine’s Hospital.

The threshold of 80,000 deaths from Covid-19 related complications was breached in SA three months ago.

Gauteng is leading the current spike in infections, driven by the Omicron variant, with the government and the private sector appealing to those still unvaccinated to get the jab to curb its further spread.

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Christian Union, CAN To File Fresh Charges Against Nigerian Government Over Controversial Act

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The Christian Association of Nigeria, (CAN) says it will file a fresh suit against the Nigerian Government to prevent the implementation of certain provisions of the Companies and Allied Matters Act (CAMA) 2020. 

The Companies and Allied Matters Act (CAMA) 2020 was signed into law by President Muhammadu Buhari in August 2020.

Also, the leadership of CAN has called for mass prayers as they take the government up in a new legal battle.

CAN had filed the suit following its last year’s rejection of the CAMA 2020, especially as it applies to the regulatory roles the law gave the registrar of Corporate Affairs Commission (CAC) and a supervising minister over churches.

The judge, Inyang Ekwo, in a judgment, dismissed the suit over the failure of the plaintiff to comply with the law in the name used in filing the originating summons.

“Therefore, this application lacks merit and ought to be dismissed and I hereby make an order dismissing same,” he ruled.

The News Agency of Nigeria (NAN) reports that while the incorporated trustees of the CAN is the plaintiff in the suit, the CAC and the Minister of Industry, Trade and Investment are the 1st and 2nd defendants, respectively.

The plaintiff, in an originating summons, marked: FHC/ABJ/CS/244/2021, had prayed the court to determine “whether Section 839, subsections (1), (7) (a) and (10) of the Companies and Allied Matters Act (CAMA), 2020, is inconsistent with Sections 4(8), 6(6)(b) and 40 of the Nigerian constitution which guarantees the plaintiff’s right to freedom of association and the right to seek redress in court”.

It also urged the court to determine whether the provisions of Section 854 of the CAMA are inconsistent with section 39 of the Nigerian constitution which guarantees the right to freedom of expression.

However, during the proceedings, CAN brought an application, praying for an order to amend the originating summons and accompanying processes by replacing the word, “INCORPORATED” with “REGISTERED” in the name of the plaintiff in the suit such that it would read, “The Registered Trustees of the Christian Association of Nigeria.”

The application was filed on the grounds that the name expressed in its certificate of incorporation is the “Registered Trustees of the Christian Association of Nigeria” and not “Incorporated Trustees of Christian Association of Nigeria.”

Justice Inyang Ekwo stated that suing in the wrong name contrary to a statutory provision is statutory non-compliance and is not a mere misnomer to be corrected by the Court, as the court cannot re-write statutory provisions. Consequently, the suit was struck out.

But on Sunday, CAN’s General Secretary, Joseph Daramola, said the organisation would not like to join issues with the Court by going on appeal, because “it would further delay the case.”

Accordingly, he said the religious body has decided to take the option of refiling the case.

“Our lawyers are currently preparing to institute a fresh suit using the proper name of the Plaintiff (CAN) as it is on the Certificate of Incorporation. This is the truth of the matter now. 

“What happened in the court was just a temporary setback and by the grace of God, we have overcome it. Our prayers are for the unborn generations and nothing will discourage us from pursuing this case to the logical conclusion,” Daramola stated.

Amongst other reliefs, CAN would be asking the Court to determine “whether Section 839, subsections (1), (7) (a) and (10) of the Companies and Allied Matters Act (CAMA), 2020, is inconsistent with Sections 4(8), 6(6)(b) and 40 of the 1999 Constitution of the Federal Republic of Nigeria (as amended) which guarantees the plaintiff’s right to freedom of association and the right to seek redress in court.

 “Whether the provision of Section 854 of the CAMA is inconsistent with Section 39 of the CFRN which guarantees the right to freedom of expression.”

It would also be seeking: “An order striking down Sections 839(1), (7) (a) & (10), 842(1) and (2), 843, 851 and 854 of the CAMA for being unconstitutional.

“A declaration that Section 17(2) (a) & (d) of the CAMA demand an impossible and impracticable action; thus, void.

“An Order striking down Section 17 (2) (a) & (d) of the CAMA for being impracticable and unknown to Law.”

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Parents bury children found dead in vehicle, amidst tears

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Mother of three of the deceased children in red

The parents of the eight children that were found dead in a Lexus SUV at Adelayo Street, Jah-Micheal Agunaje area of Badagry, have buried them amidst tears.

The eight children were found dead in a vehicle parked in front of the owner’s compound on Saturday evening.

The children were buried according to Islamic rites on Sunday morning, without an autopsy conducted on them.

Mark Akande, the founder of Society for Youth Advancement and Creativity Initiative (SHACo), who visited the scene on Sunday, gathered that the incident happened around 5p.m. on Saturday and the children were buried after attempts to conduct autopsy on them failed.

The parents reportedly took the children to the General Hospital at Badagry, and the Lagos University Teaching Hospital (LUTH), where they were told to bring N100, 000 each for the hospital to conduct autopsy on the children.

“The parents decided not to take them for autopsy at LUTH. They said it is against Islamic laws to spend money on the dead,” Mr Akande said.

The police spokesperson, Adekunle Ajisebutu, earlier confirmed that the children reportedly entered a parked vehicle while playing around and died from suffocation.

One of the elders in the neighbourhood, who declined giving his name, said the children were supposed to be at Islamic lessons at the time of the incident, and no one suspected that they had entered a parked vehicle.

Afsat Isiaka, a mother who lost three children to the incident, was found in a mourning state amidst sympathisers in her compound, which was close to where the incident happened.

“I know no wetin happen, my second sef go find the children, the woman sef stay inside compound and call me say make I come, na so I find the children inside car, all of children don die, ” she said in pidgin English.

She said the children were foaming in the mouth by the time they were brought down from the vehicle.

Her children, Abdulwahab Isiaka, Yakub Isiaka, and Zainab Isiaka were 11, 5 and 3 years old respectively.

Ibrahim Jubril, a father to two of the deceased children, was also found surrounded by sympathisers in his compound.

Father of two deceased children, Ibrahim Jubril
Father of two deceased children, Ibrahim Jubril

Mr Jubril said they had already recovered the bodies of the children before he got to the scene.

“They said they wan carry them to hospital and me I be Muslim. We carried then to General Hospital, that same yesterday, police gave us paper, they say they want to transfer us to Ikeja, LUTH. They said each person is N100, 000 to check, that is N800, 000 for eight of them,” he said.

He said he has written a statement at the police station with respect to the incident.

TEXEM

Mr Jubril’s immediate brother also lost two children to the incident, while one of the eight children is the grandson of the owner of the vehicle, PREMIUM TIMES gathered.

The woman in whose car the children were found dead is currently in custody of the Area K Police Command in Badagry, Lagos.

Mr Ajisebutu, the police spokesperson, said the police is investigating the matter and would carry the public along on the report.

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