Iceland on Oct. 8 halted the use of the Moderna vaccine against the CCP virus due to reports from Nordic countries of “increased incidence” of inflammation of heart muscle and tissues triggered by the injection.
Sweden, Finland, Denmark, and Norway have already limited the use of the Moderna vaccine over the same concerns. Iceland went further than its neighbors and stopped using the vaccine entirely.
“In recent days, there has been data from the Nordic countries on the increased incidence of myocarditis and pericarditis after vaccination with Moderna vaccine in addition to vaccination with Pfizer/BioNTech (Comirnaty),” an announcement from Iceland’s Directorate of Health stated.
“As there is a sufficient supply of Pfizer vaccine in Iceland for both the pre-vaccine activation vaccines and the primary vaccinations of those who have not yet been vaccinated, the epidemiologist has decided not to use the Moderna vaccine in Iceland, while providing further information on the safety of the Moderna vaccine.”
Sweden limited the use of the Moderna shot on Oct. 6 to those born before 1991. The Swedish health agency said at the time that new data from Swedish and other Nordic sources “indicate that the connection is especially clear” between Moderna’s vaccine and side effects “especially after the second dose.”
“Both myocarditis and pericarditis often go away on their own, without causing any lasting problems, but suspicious symptoms should be assessed by a doctor at … a health center or emergency room,” the agency stated, noting that “medical treatment and monitoring in hospital may be needed in established cases.”
Norway and Denmark have recommended the Pfizer vaccine for children aged 12-17. In Iceland, only the Pfizer vaccine has been recommended for the 12-17 age group.
Finland on Oct. 7 discontinued the use of the Moderna shot for men under the age of 30.
That decision came one day after Sweden and Denmark halted the use of the vaccine for the younger age groups.
Iceland had been using the Moderna vaccine almost exclusively as a booster shot for those who received the Johnson&Johnson vaccine, according to the Health Directorate. The Nordic nation had also been using the Moderna vaccine as a booster for two-dose vaccinations of the elderly and immunocompromised.
According to the World Health Organization, more than 75 percent of Iceland’s population has been fully vaccinated against the CCP (Chinese Communist Party) virus, commonly known as the novel coronavirus, which causes COVID-19.
A total of 33 people died from COVID-19 in Iceland since the start of the pandemic.
Ivermectin: misuse against COVID risks undermining its use for other diseases
Ivermectin is vital for controlling a number of neglected tropical diseases, but mixed messaging and reported side-effects from its misuse against COVID could turn patients off it.
If you live in a western country, prior to the pandemic you probably hadn’t heard of the medicine ivermectin. It’s a very effective treatment for a number of neglected tropical diseases (NTDs). These are a group of debilitating infections that can cause chronic illness and death. They disproportionately affect the world’s most vulnerable and deprived people.
Examples of NTDs include lymphatic filariasis and onchocerciasis, two worm-based infections that are spread by mosquitoes, and scabies, which is spread by the infestation of the skin with mites. All of these can be treated with ivermectin.
Hundreds of millions of ivermectin doses are administered every year, mostly across lower-income countries. In 2020, the World Health Organization (WHO) published a new roadmap for bringing cases of NTDs down worldwide over the next decade, with ivermectin being integral to this. It will be used to prevent and treat NTDs across many countries, including through mass drug administration.
But during the pandemic, ivermectin has also been touted as a COVID treatment. Despite a lack of good evidence to back this up, some countries have recommended ivermectin as part of their pandemic response. Panama and other parts of Latin America, for example, have endorsed using the drug. So too did India, before the Indian Council of Medical Research specified that the evidence isn’t there to support its use.
A Cochrane Review – a reliable wide-ranging piece of research that analyses the results of many separate pieces of research on a topic – has concluded that the evidence available so far on using ivermectin to treat COVID patients, both inside and outside of hospital, is of low quality.
Other wide-ranging reviews have suggested that the drug is beneficial against COVID, but scientists have flagged that some of the papers covered by these reviews use data inappropriately, with some of the research possibly even being fraudulent. Because the research these reviews are assessing isn’t rigorous, any suggestions they make about benefits aren’t robust.
The WHO has therefore advised that ivermectin shouldn’t be used as part of routine clinical practice when treating COVID. The drug’s manufacturer, Merck, has added that there’s “no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease”.
Confusion undermines trust
This, my colleagues and I argue, leads us into a dangerous situation. Any health intervention depends upon high trust and uptake for success. If people consider ivermectin to be a COVID treatment, then there is a risk that these perceptions may lower trust in the drug as a way of treating NTDs.
For instance, people taking the drug without medical supervision to try to treat or prevent COVID have experienced vomiting, diarrhoea, seizures, dizziness and rashes. This may be because they have overdosed – so wouldn’t indicate a problem with the drug – but nevertheless risks undermining ivermectin’s perceived safety.
Reports of illness after taking ivermectin could have dangerous consequences. Even before the pandemic, in the UK there were rumours about ivermectin that have proven hard to dispel. These concerned the safety of using the drug to treat scabies infections in the elderly. Despite these claims being unsubstantiated, they still deter clinicians from using the drug. Fake news can be hard to fully correct, and could be even more so if negative perceptions build.
Conflicting messaging can also be a problem. Its use for COVID being disputed, and it being endorsed by the WHO as an NTD treatment but rejected as a COVID treatment, could lead to doubts and misinformation surrounding the drug. Once misinformation is released, it can easily spread. It then takes resources to address and correct false claims that are made. In lower-income settings, such resources will be in short supply.
High uptake is key against NTDs
If there’s significant mistrust in public health programmes that use ivermectin, then the targeted elimination of some NTDs becomes very unlikely. These programmes often revolve around mass administration of the drug, and so are only highly successful in reducing the burden of disease when there’s high uptake.
Success can be limited if there is frequent non-adherence to treatment programmes. This can be an issue when rumours (typically around side-effects) are common.
The WHO’s NTD roadmap has a target to globally eliminate lymphatic filariasis as a public health problem by 2030. There are 17 countries – including Togo, Malawi and Sri Lanka – that have so far used mass administration of ivermectin to successfully eliminate the disease. Other countries are probably going to need to use the drug the same way – but could struggle to stamp the disease out if reports of side-effects or seemingly conflicting advice about the treatment deter people from taking it.
Ivermectin is an excellent medicine. Appropriate use of it will be vital to lowering the burden of NTDs and hitting the targets within the WHO’s roadmap. But to make sure its usefulness isn’t undermined, trust in the drug must not be threatened – and this means its misuse as a COVID treatment needs to end.
Michael Head has received funding from the Bill & Melinda Gates Foundation and the UK Department for International Development.treatment pandemic covid-19 spread india uk world health organization
Pfizer Inc. (NYSE: PFE) Anticipating Vaccine Approval for Children Above 5, US Government Donates Vaccine to Nigeria
The US White House has informed governors to prepare for vaccination of children from five years from next month in anticipation of approval of Pfizer Inc. (NYSE: PFE) and BioNTech SE’s (NASDAQ: BNTX) COVID-19 vaccine for the age group in the coming…
The US White House has informed governors to prepare for vaccination of children from five years from next month in anticipation of approval of Pfizer Inc. (NYSE: PFE) and BioNTech SE’s (NASDAQ: BNTX) COVID-19 vaccine for the age group in the coming weeks.
Already the Biden administration has bought 65 million pediatric doses of the vaccine, which is enough to vaccinate around 28 million kids who will be eligible once the FDA approves the vaccine for children between 5 and 11 years.
Drugmakers aren’t doing enough to end the coronavirus pandemic
Pfizer and Moderna (NASDAQ: MRNA) have been doing an excellent job in the fight against the pandemic. Their CEOs are will receive the Edward M. Kennedy Institute Award for Inspired Leaders for creating the coronavirus vaccines. Moderna CEO Stephane Bancel and Pfizer’s CEO Albert Bourla will receive the award on December 2, 2021.
Drug companies are in the race to end the Coronavirus pandemic, but their failure to ramp up manufacturing could prolong the pandemic and cost lives. The only way to avert this is by having the Pfizer, and Moderna duopoly is broken in mRNA vaccine production. As a result, people are receiving less effective vaccines or whose protection wanes against variants which means more booster doses and selling of vaccines to countries depending on ability to pay and not need. For the companies that have distributed almost 1 billion doses between them, it means more business.
The US donates Pfizer vaccine to Nigeria.
The US government is donating 3.5 million Pfizer vaccine doses to Nigeria. A White House official said, “We are sharing these doses not to secure favors or extract concessions. Our vaccines do not come with strings attached. We are doing this with the singular objective of saving lives.”
Panama approved Pfizer’s COVID-19 booster vaccine for high-risk individuals, including hospitalized patients, healthcare providers, people above 55, and nursing home residents.
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FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids
FDA advisors will meet later today discuss the possibility of authorising Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in
The post FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids appeared first on .
FDA advisors will meet later today discuss the possibility of authorising Pfizer and BioNTech’s COVID-19 vaccine Comirnaty in children as young as five years old.
If the Vaccines and Related Biological Products Advisory Committee (VRBPAC) gives the go-ahead, the FDA could approve emergency-use of Comirnaty in five to 11-year-olds in a matter of days, extending the use of the vaccine from its current 12 and upwards bracket.
The advisors could also be called on to consider Moderna’s COVID-19 as well for younger children in the coming weeks, as the biotech has just reported positive interim results from a phase 2/3 trial of its mRNA-1273 shot in kids aged six to 11.
Moderna has said it plans to submit the new data to global regulators including the EMA and FDA shortly.
While the data for both vaccines on stimulating an immune response in younger children looks strong, attention at the advisory committee meeting is expected to focus on safety – and particularly the risk of heart inflammation that has been observed in some recipients.
Both the mRNA vaccines have been linked to cases of myocarditis and pericarditis, particularly in males, so the advisors will have to consider whether that risk outweighs the benefits of vaccination in an age group known to be less likely to develop severe COVID-19.
Pfizer/BioNTech and Moderna have said their clinical trials haven’t generated any additional safety signals in children compared to adults.
Nevertheless, some children with COVID-19 do get very ill, and the risk of so-called ‘long COVID’ – where debilitating symptoms can persist for months even after a mild infection – has led to calls for jabs to be administered as widely as possible.
Vaccinating younger school-age children could also help to reduce circulation of SARS-CoV-2, according to some experts. Pfizer and BioNTech are also running studies in the under-fives with results due later this year.
Pfizer chief executive Albert Bourla said recently that the spread of the delta variant and the “substantial threat” it poses to children means that vaccination should be offered to younger age groups.
As of 21 October, nearly 6.3 million children in the US had tested positive for COVID-19 since the onset of the pandemic, with 118,000 new cases in the previous week and more than a million in the preceding month, according to the American Academy of Paediatrics (AAP).
“At this time, it appears that severe illness due to COVID-19 is uncommon among children,” said the AAP in a recent update.
“However, there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”
Comirnaty is already authorised in the US for children aged 12 and above, while mRNA-1272 is currently being reviewed for this age group.
A recent Wall Street Journal report suggested however that the FDA is delaying a decision on Moderna’s jab until it completes a review of its heart inflammation risks, amid some speculation they may be higher than with the Pfizer/BioNTech shot.
Earlier this month, Sweden, Finland and Norway temporarily suspended use of mRNA-1273 in younger people, saying they should be vaccinated with Comirnaty instead, while a review of safety data is undertaken.
The post FDA advisors mull use of Pfizer/BioNTech COVID-19 jab in kids appeared first on .vaccine fda clinical trials pandemic covid-19 spread new cases sweden
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