Moderna

Slowing Vaccine Take-Up Means 170,000 Moderna Doses at Risk of Expiry

The NHS is looking to redistribute thousands of Covid vaccine doses as slowing take-up rates among young Britons, who don’t appear to be moved by petty bribes, could result in doses being thrown away after reaching their expiry dates. The Guardian has the story.

An internal email seen by the Guardian warned of 170,000 doses of the Moderna vaccine at risk of expiry within the next fortnight, as doctors across England have raised alarm at the unpredictability of vaccine take-up among young people meaning more doses will go to waste.

The Government is to unveil a raft of new initiatives to increase vaccine uptake among young people, including discounts on car-hailing companies such as Uber and Bolt, as well as the delivery service Deliveroo.

It is understood the NHS has managed to redistribute 40,000 of the spare Moderna jabs. However, concerns have been raised about the number of jabs wasted as uptake slows among younger people eligible for the Moderna and Pfizer jabs.

The Joint Committee for Vaccination and Immunisation recommends an interval of eight to 12 weeks between doses, initially as a way to offer more people first doses because of limited supply, but studies have since shown that the larger gap could give longer protection.

One NHS doctor in the north-east, Dr Alison George, said colleagues had been forced to routinely discard Pfizer doses, rather than give second shots early to people who requested them. “We have very high rates of infection here and the local hospital is already under significant pressure with some elective surgery cancelled,” the GP said. …

Beccy Baird, a Senior Fellow at The King’s Fund, said it was getting more difficult to predict vaccine uptake.

“Uptake is getting lower as the cohorts get younger and matching the supply of vaccines to demand will get harder as demand becomes less predictable. This is made all the harder as the vaccines have a limited shelf life,” she said. …

“In the early stages of the rollout, you could be confident that wherever vaccines were delivered there would be sufficient demand for them. Now that a majority of adults have been vaccinated, and with uptake getting lower as the cohorts become younger, demand for the vaccine is more unpredictable, making it harder to know exactly where the doses are needed.” …

Pfizer and Moderna vaccines are now mostly distributed to the under-40s, who cannot receive the AstraZeneca vaccine. Those vaccines have a shorter shelf life of up to one month in the fridge, compared with the AstraZeneca vaccine, which can last for up to six months.

Worth reading in full.

Man Dies from Blood Clot after Taking Moderna Covid Vaccine

Cases of blood clotting after vaccination have mainly been associated with the AstraZeneca Covid vaccine over recent months, but an American man, aged 65, has now died 12 days after his second dose of the Moderna vaccine in what is being reported as the first known death from blood clotting linked to this vaccine. The Sun has the story.

After getting the coronavirus jab, the man experienced pain in both legs, difficulty breathing and was diagnosed with thrombosis with thrombocytopenia syndrome (TTS) two days before he died.

Three days into his stay at Allegheny Health Network in Pittsburgh, Pennsylvania, the man developed cerebral venous sinus thrombosis, according to a report published on the Annals of Internal Medicine website.

This is a rare type of blood clot blocking the brain’s sinus channels of draining blood, which could lead to hemorrhages. 

Doctors searched to identify other causes behind his TTS including Covid, other viruses or thrombotic thrombocytopenia purport, a rare disorder that causes blood clots throughout the body.

The man had chronic underlying conditions including high blood pressure and hyperlipidemia, which presents itself when high levels of fat particles are in the blood.

Despite “rapid and exhaustive” treatment eliminating all other options, a solution could not be found leaving investigators believing the blood clots were caused by the vaccine.

Previously, research showed that the “rare but life-threatening” condition only occurred in individuals who received Johnson & Johnson or AstraZeneca vaccines.

Both vaccines combine genetic material taken from the coronavirus and genes of the adenovirus, producing an immune response.

The findings show that the side effects can also occur when someone gets a vaccine that has messenger RNA (mRNA).

Because blood clots do occur after vaccinations, the report claims, “it should not dissuade people from getting the Covid jab”.

Earlier this month, the U.S. Food and Drug Administration announced that it would add a warning to the Moderna vaccine – as well as the Pfizer vaccine – after the Centers for Disease Control and Prevention said there is a “likely link” between them and cases of heart inflammation, particularly in children and young adults.

The Sun report is worth reading in full.

U.S. Medicines Regulator to Add Warning to Pfizer and Moderna Vaccines Over Link to Heart Inflammation

The U.S. Food and Drug Administration (FDA) is set to add a warning to the Covid vaccines made by Pfizer and Moderna after the Centers for Disease Control and Prevention (CDC) said there is a “likely link” between them and cases of heart inflammation, particularly in children and young adults. The MailOnline has the story.

The CDC made the announcement Wednesday during a presentation. 

The Covid Vaccine Safety Technical (VaST) Work Group discussed nearly 500 reports of heart inflammation, known as myocarditis, in vaccinated adults under the age of 30.

The group of doctors said the risk of myocarditis or pericarditis following vaccination with the mRNA-based shots in adolescents and young adults is notably higher after the second dose and in males  

It comes as the Advisory Committee on Immunisation Practices (ACIP) is set to meet this week to assess the possibility of a link between the heart condition and the mRNA vaccines. 

The Moderna and Pfizer vaccines use mRNA technology, while the Johnson & Johnson vaccine uses the more traditional virus-based technology. 

According to the presentation, there have been 484 preliminary reports of myocarditis or pericarditis in young people under age 30 as of June 11th.

So far, 323 have been confirmed by CDC and 148 are still under review.

In total, 309 patients were hospitalized, of which 295 were discharged and 79% have since recovered.

Nine patients are still hospitalized with two in intensive care units. There was no data available for five patients. 

Males were much more likely to report heart inflammation after receiving a second dose than women.

As of June 11th, there were 9.1 per million reported cases of myocarditis/pericarditis in females ages 12-to-17 compared to 66.7 per million in males of that age group.

What’s more, rates among females ages 18-to-24 and ages 25-to-29 were 5.5 per million and 2.6 per million respectively.

Ang [among] males, rates were 56.3 per million for the 18-to-24 age group and 20.4 per million in the 25-to-29 group.

In Australia, the AstraZeneca Covid vaccine is facing further criticism over its links to a variety of side effects. The vaccine will have been almost completely phased out of the country’s roll-out by October.

Worth reading in full.

CDC to Hold Emergency Meeting Over 226 Cases of Heart Inflammation in American Teens Who Have Had Pfizer or Moderna Vaccines

The U.S. Centers for Disease Control is set to hold an emergency meeting over a greater than expected number of cases of heart inflammation among young Americans who have received two doses of either the Pfizer or Moderna Covid vaccine. The MailOnline has the story.

[CDC leaders] will gather on June 18th to discuss 226 plausible cases of heart inflammation in young people – mainly affecting teenage boys and young men – after they have received their second doses of the vaccines. 

CDC bosses said Thursday the number of cases is higher than expected, although still rare.

[CNBC reports that, according to the CDC, scientists expected only between 10-102 cases of myocarditis or pericarditis.]

A total of 226 cases have been reported that may meet the CDC’s “working case definition” of myocarditis and pericarditis following the shots, the agency said. 

Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart.

Among the 226, three are in intensive care, 15 are hospitalised, and 41 have ongoing symptoms. The rest – 167 – have recovered.  

It is not clear if either condition is caused by the shots and the reports of cases are extremely rare. 

The CDC continues to urge everyone aged 12 and older to get vaccinated.

These types of heart inflammation can be caused by a variety of infections, including a bout of Covid, as well as certain medications…

Cases are reported through the U.S. Vaccine Adverse Event Reporting System (VAERS).

The system accepts reports from everyone regardless of the plausibility of the vaccine causing the symptom.

In total, VAERS received 573 reports of myocarditis and pericarditis after the patient had received their second dose. 

A total of 372 reports were from people who had the Pfizer vaccine, while the remaining 201 had Moderna.

Another 216 cases of the heart inflammation were also reported after dose one of the vaccines. 

More than half of the cases reported after people had received their second dose were in people between the ages of 12 and 24, the CDC said.  

This group accounts for less than nine per cent of doses administered.  

Almost four-fifths of cases were in males. 

The overwhelming majority of the cases have occurred within a week of vaccination. 

Symptoms included chest pain and breathing difficulties. 

This comes just one day after Moderna asked the U.S. Food and Drug Administration to extend the emergency use of its Covid vaccine to American children aged 12 and over.

The U.K. Medicines and Healthcare products Regulatory Agency approved the use of the Pfizer vaccine in British children aged 12-15 earlier this month, though the Joint Committee on Vaccination and Immunisation said that the decision on whether or not to vaccinate children against Covid is down to the Government given that it is a “political” matter. So far, the petition on the Gov.uk website against the vaccination of children has been signed by over 50,000 people.

Worth reading in full.

Stop Press: Watch Tucker Carlson react to this news.

Moderna Hopes Its Covid Vaccine Will Be the Second to Be Authorised for Use in American Children

Moderna has asked the U.S. Food and Drug Administration (FDA) to extend the emergency use of its Covid vaccine to American children aged 12 and over. The FDA approved the use of the Pfizer Covid vaccine in children a month ago on Thursday, and earlier this month the U.K.’s medicines regulator did the same for British children. The MailOnline has more.

When the [Moderna] vaccine was originally authorised for use by the FDA in December 2020, it was only for those aged 18 and older. 

However, recent Phase Three clinical trial data showed no children who were given the immunisation fell ill with the virus within 14 days of their second dose, while four children given the placebo later tested positive.

According to Moderna, this is “consistent with a vaccine efficacy of 100%”.

It comes exactly four weeks after Pfizer received approval from the FDA to administer its vaccine to children between ages 12 and 15. 

As of Thursday, more than seven million U.S. children between ages 12 and 17 have received at least one dose of the vaccine.

Still, only about one in three parents said they would immunise their children right away.

Although children can contract Covid and pass the disease on to others, they tend to not get very ill and make up about 0.1% of deaths.

“We are pleased to announce that we have submitted for an emergency use authorization for our Covid vaccine with the FDA for use in adolescents in the United States,” said Moderna CEO Stéphane Bancel in a statement

“We are encouraged that the Moderna Covid vaccine was highly effective at preventing Covid and SARS-CoV-2 infection in adolescents.”…

Moderna’s study included 3,732 adolescents from ages 12 to 17 enrolled at sites across the U.S….

Side effects were mild or moderate with the most common being pain at the site of injection, similar to adults in the clinical trial last year.

Other common symptoms were fatigue, headache, muscle pain and chills, but no serious side effects were reported. 

Worth reading in full.

New Study From Harvard Shows “Systemic” Presence of Spike Proteins in Blood Following Vaccination

A new paper published this week in Oxford scientific journal Clinical Infectious Diseases has shown that the spike protein from an mRNA Covid vaccine is present systemically in the blood from the day of the jab and is not localised to the site of injection. The research team from Harvard found the protein in the blood of 11 of 13 nurses tested following vaccination. Here is the abstract:

SARS-CoV-2 proteins were measured in longitudinal plasma samples collected from 13 participants who received two doses of mRNA-1273 [Moderna] vaccine. 11 of 13 participants showed detectable levels of SARS-CoV-2 protein as early as day one after first vaccine injection. Clearance of detectable SARS-CoV-2 protein correlated with production of IgG and IgA.

The Covid vaccines introduce genetic material into the body which give our cells instructions to produce the spike protein, which the immune system then learns to fight off and produces antibodies against. It had not previously been confirmed whether the spike protein was only produced locally to the injection site or could be detected more widely in the body.

The implications of this finding are unclear. As the authors state: “The clinical relevance of this finding is unknown and should be further explored.” However, it would seem to explain why side-effects potentially connected to the spike protein can occur throughout the body and are not localised to the injection site.

Pfizer and Moderna Vaccines to Be Offered to Under-40s From Thursday

The Covid vaccine rollout is set to extend to those below the age of 40 from Thursday, with the Pfizer and Moderna vaccines being offered as alternatives to that made by AstraZeneca “where possible”. MailOnline has the story.

An NHS bulletin showed adults aged 38 and 39 will be invited to come forward for their jab from Thursday morning.

They will be offered either the Pfizer or Moderna vaccine on the back of guidance from medical regulators last week.

The Joint Committee on Vaccination and Immunisation (JCVI) said under-40s should be given an alternative to the AstraZeneca jab due to its link to rare blood clots.

The NHS Digital bulletin said 38 and 39 year-olds already booked in for a first dose of the British vaccine will have their appointment cancelled…

The vaccine rollout is currently in phase two – which includes people between 20 to 49 – and is moving down by age. 

The Government says it is on track to fully vaccinate every adult in Britain by the end of July.

Everyone in phase one of the scheme, which included elderly people and patients with underlying health conditions, has already been offered a vaccine.

Uptake is thought to be around 90% in the over-60s U.K.-wide, while coverage in the over-50s is above 50% and still climbing. Over-50s only started to be invited last month…

The JCVI – which advises the Government on how best to vaccinate the population – said younger people should be offered an alternative to the AZ jab because of its link to blood clots. 

So far regulators have spotted major blood clots in 242 people given the AZ vaccine, of whom 49 died. But they are occurring more in younger adults, with a rate of around one in 60,000 under-40s.

Experts said the infection rate in the U.K. is now so low that the risk of the rare clots outweighs that of Covid in younger adults, who often only suffer mild illness. 

They will be offered the Pfizer or Moderna vaccines instead, so long as there is enough supply and it won’t delay the rollout.

Given that the risk of blood clots after taking the AstraZeneca vaccine outweighs the risk of Covid in younger adults, it is strange that the JCVI has only advised for alternatives to be given “where possible and only where no substantial delay would arise“. Why not just restrict its use for those below the age of 40 altogether?

The MailOnline report is worth reading in full.

England’s Rollout of the Moderna Vaccine Begins

England is to begin giving out doses of the Moderna jab – the third vaccine introduced in its national rollout – as everyone over the age of 50 is offered their first dose of a vaccine. Bookings are also opening online for those aged 45-49 to get vaccinated. Wales was the first British country to begin rolling out the Moderna jab last week and has since reached the milestone of vaccinating half of its population. Seventeen million doses of the vaccine have been bought by the Government, which is enough to vaccinate about 8.5 million people. BBC News has the story.

England is giving out its first doses of the Moderna jab, the third Covid vaccine in the nation’s rollout.

It will be available at 21 sites, including the Madejski Stadium in Reading and the Sheffield Arena. …

More than 32 million people in the UK have now had a first dose of a coronavirus vaccine and nearly 7.7 million have had both doses.

Prof Stephen Powis, Medical Director of NHS England, said having “a third jab in our armoury” marked another “milestone” in the vaccine programme.

He said more sites would offer the Moderna vaccine as further supplies arrive. …

The Moderna vaccine uses a similar innovative RNA technology to the Pfizer jab, but it is stored at lower temperatures of -20C like a normal freezer, compared to -70C for the Pfizer vaccine. It can also be stored for 30 days at normal fridge temperatures. …

Trial results suggested efficacy against the disease was 94.1%, and vaccine efficacy against severe Covid-19 was 100%.

More than 30,000 people in the US took part in the trial, from a wide range of age groups and ethnic backgrounds.

The vaccine will be used alongside Pfizer’s Covid jab as an alternative to that produced by AstraZeneca for people below the age of 30 (possibly even those aged 30-39) because of the AZ jab’s link to blood clots.

The NHS said the Moderna and Pfizer jabs would be used for under-30s who were due to receive the AstraZeneca vaccine but whose appointments were rearranged.

Last week, the Joint Committee on Vaccination and Immunisation – which advises the UK Government on vaccines – recommended that under-30s be offered an alternative to the AstraZeneca vaccine, out of the “utmost caution” following reports of blood clots in about four in one million cases.

The NHS said the majority of appointments in April were for second doses, but first dose appointments were still available for people in the initial priority groups who have not yet been immunised – including the over-50s, people who are clinically vulnerable or those working in health or social care.

The vaccine will, however, only be offered as an alternative where possible.

The BBC News report is worth reading in full.

British Rollout of the Moderna Covid Vaccine Begins as AstraZeneca Supply Dries Up

Britain’s rollout of the Moderna vaccine began today amid disruptions in its supply of the AstraZeneca jab which faces continuing scrutiny regarding its connection to rare blood clots. Reuters has the story.

Britain began using Moderna’s Covid vaccine on Wednesday in Wales just as its rollout of other shots fell to their lowest level this year due to a supply crunch caused by manufacturing problems at AstraZeneca.

Britain has surged ahead of the rest of Europe in the race to vaccinate its population, with almost half of its citizens receiving a first dose. But supply issues from its main AstraZeneca shot have slowed progress in recent days.

Britain distributed almost 96,000 shots on Sunday and just over 105,000 on Monday, the lowest figures since the Government started publishing daily numbers in January.

It had warned that the rollout would slow in April due to AstraZeneca’s manufacturing issues, including at a site in India.

A spokesman for Prime Minister Boris Johnson said that he would not go into details about supply and delivery timelines but said the country remained on track to provide a first dose to all adults by the end of July.

That rollout will now be bolstered by the addition of the Moderna shot. Already used in the United States and other parts of Europe, it becomes the third vaccine to be used in Britain after AstraZeneca and one from Pfizer.

The Prime Minister has welcomed the arrival of the Moderna vaccine, saying that 17 million doses of the jab have been ordered.

The disruption to the supply of the AstraZeneca vaccine comes as the jab is under scrutiny regarding its link to rare blood clots. Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) are due to give an update on this issue shortly.

The Reuters report is worth reading in full.