COPENHAGEN, Denmark: Swedish health authorities on Wednesday suspended the use of Moderna’s COVID-19 vaccine for those ages 30 and under, saying the move was done out of precaution.
The reason for the pausing is “signals of an increased risk of side effects such as inflammation of the heart muscle or the pericardium” — the double-walled sac containing the heart and the roots of the main vessels, Sweden’s Public Health Agency said in a statement. “The risk of being affected is very small.”
Anders Tegnell, Sweden’s chief epidemiologist, said they “follow the situation closely and act quickly to ensure that vaccinations against COVID-19 are always as safe as possible and at the same time provide effective protection” against the disease.
In July, the European Medicines Agency recommended authorizing Moderna’s COVID-19 vaccine for children ages 12 to 17, the first time the shot has been authorized for people under 18.
Moderna’s vaccine was given the green light for use in anyone 18 and over across the 27-nation European Union in January. It has also been licensed in countries including Britain, Canada and the US, but so far its use hasn’t been extended to children. To date, the Pfizer/BioNTech vaccine is the only one approved for children under 18 in Europe and North America.
Hundreds of millions of Moderna doses already have been administered to adults. In a study of more than 3,700 children ages 12 to 17, the vaccine triggered the same signs of immune protection, and no COVID-19 diagnoses arose in the vaccinated group compared with four cases among those given dummy shots.
Sore arms, headache and fatigue were the most common side effects in the young vaccine recipients, the same ones as for adults.
US and European regulators caution, however, that both the Moderna and Pfizer vaccines appear linked to a rare reaction in teenagers and young adults — chest pain and heart inflammation.
The Swedish health authorities said that the heart symptoms “usually go away on their own,” but they must be assessed by a doctor. The conditions are most common among young men, in connection with, for example, viral infections such as COVID-19. In 2019, approximately 300 people under the age of 30 were treated in hospital with myocarditis.
Data point to an increased incidence also in connection with vaccination against COVID-19, mainly in adolescents and young adults and mainly in boys and men.
New preliminary Nordic analyzes indicate that the connection is especially clear when it comes to Moderna’s vaccine, especially after the second dose, the agency said.
“The increase in risk is seen within four weeks after the vaccination, mainly within the first two weeks,” it said.
The Swedish agency said the vaccine from Pfizer is recommended for these age groups instead. Its decision to suspend the Moderna vaccine is valid until Dec. 1.
In Denmark, people under the age of 18 won’t be offered the Moderna vaccine out of precaution, the Danish Health Authority said Wednesday. It said that data, collected from four Nordic countries, show that there is a suspicion of an increased risk of heart inflammation when vaccinated with Moderna shots, although the number of cases of heart inflammation remains very low.
The preliminary data from the Nordic study have been sent to the European Medicines Agency’s adverse reaction committee and will now be assessed.
The study was conducted by Denmark’s Statens Serum Institute — a government agency that maps the spread of the coronavirus in the country — the Medical Products Agency in Sweden, the National Institute of Public Health in Norway and the Institute for Health and Welfare (THL) in Finland. The final results were expected in about a month, the Danish official said.
In Denmark, children and young people ages 12-17 have primarily been invited to receive the COVID-19 vaccine from Pfizer/BioNTech.
“Based on the precautionary principle, we will in future only invite children and young people to receive this vaccine, not least in view of the fact that it is for this vaccine that the largest amount of data from use exists for children and young people, especially from the USA and Israel, said Bolette Soeborg of the government health agency.
Sweden suspends Moderna vaccine for those 30 and under
https://arab.news/66ysv
Sweden suspends Moderna vaccine for those 30 and under
- The reason for the pausing is “signals of an increased risk of side effects such as inflammation of the heart muscle or the pericardium”
- Sweden’s chief epidemiologist said they “follow the situation closely and act quickly to ensure that vaccinations against COVID-19 are always as safe as possible”
WHO chief says reasons US gave for withdrawing ‘untrue’
- US Secretary of State Marco Rubio and US Health Secretary Robert F. Kennedy Jr. announced in a joint statement Thursday that Washington had formally withdrawn from the WHO
- And in a post on X, Tedros added: “Unfortunately, the reasons cited for the US decision to withdraw from WHO are untrue”
GENEVA: The head of the UN’s health agency on Saturday pushed back against Washington’s stated reasons for withdrawing from the World Health Organization, dismissing US criticism of the WHO as “untrue.”
Tedros Adhanom Ghebreyesus warned that US announcement this week that it had formally withdrawn from the WHO “makes both the US and the world less safe.”
And in a post on X, he added: “Unfortunately, the reasons cited for the US decision to withdraw from WHO are untrue.”
He insisted: “WHO has always engaged with the US, and all Member States, with full respect for their sovereignty.”
US Secretary of State Marco Rubio and US Health Secretary Robert F. Kennedy Jr. announced in a joint statement Thursday that Washington had formally withdrawn from the WHO.
They accused the agency, of numerous “failures during the Covid-19 pandemic” and of acting “repeatedly against the interests of the United States.”
The WHO has not yet confirmed that the US withdrawal has taken effect.
- ‘Trashed and tarnished’ -
The two US officials said the WHO had “trashed and tarnished” the United States, and had compromised its independence.
“The reverse is true,” the WHO said in a statement.
“As we do with every Member State, WHO has always sought to engage with the United States in good faith.”
The agency strenuously rejected the accusation from Rubio and Kennedy that its Covid response had “obstructed the timely and accurate sharing of critical information that could have saved American lives and then concealed those failures.”
Kennedy also suggested in a video posted to X Friday that the WHO was responsible for “the Americans who died alone in nursing homes (and) the small businesses that were destroyed by reckless mandates” to wear masks and get vaccinated.
The US withdrawal, he insisted, was about “protecting American sovereignty, and putting US public health back in the hands of the American people.”
Tedros warned on X that the statement “contains inaccurate information.”
“Throughout the pandemic, WHO acted quickly, shared all information it had rapidly and transparently with the world, and advised Member States on the basis of the best available evidence,” the agency said.
“WHO recommended the use of masks, vaccines and physical distancing, but at no stage recommended mask mandates, vaccine mandates or lockdowns,” it added.
“We supported sovereign governments to make decisions they believed were in the best interests of their people, but the decisions were theirs.”
- Withdrawal ‘raises issues’ -
The row came as Washington struggled to dislodge itself from the WHO, a year after US President Donald Trump signed an executive order to that effect.
The one-year withdrawal process reached completion on Thursday, but Kennedy and Rubio regretted in their statement that the UN health agency had “not approved our withdrawal and, in fact, claims that we owe it compensation.”
WHO has highlighted that when Washington joined the organization in 1948, it reserved the right to withdraw, as long as it gave one year’s notice and had met “its financial obligations to the organization in full for the current fiscal year.”
But Washington has not paid its 2024 or 2025 dues, and is behind around $260 million.
“The notification of withdrawal raises issues,” WHO said Saturday, adding that the topic would be examined during WHO’s Executive Board meeting next month and by the annual World Health Assembly meeting in May.
“We hope the US will return to active participation in WHO in the future,” Tedros said Saturday.
“Meanwhile, WHO remains steadfastly committed to working with all countries in pursuit of its core mission and constitutional mandate: the highest attainable standard of health as a fundamental right for all people.”
