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FDA approves unpopular bivalent Covid booster vaccines for BABIES

FDA approves unpopular bivalent Covid shot for BABIES and ‘encourages parents to get their child vaccinated before the holidays’

  • Agency green-lit plans for updated shot to be given as part of three-dose course
  • Children aged six months to four years will get bivalent as their third mini dose
  • Yet the booster shots are very unpopular among adults – with uptake at just 13%

US health officials today approved Pfizer and Moderna’s bivalent Covid vaccines for babies, in a move bound to draw criticism.

The Food and Drug Administration (FDA) has green-lit plans for the updated shots to be given as part of a three-dose course for children aged six months to four years.

Agency officials said they ‘encourage parents and caregivers’ to get their child vaccinated ‘especially as we head into the holidays and winter months’.

It comes after a study found the bivalent vaccines are significantly weaker against a rising Covid variant expected to become dominant in the US in months.

US health officials today approved Pfizer and Moderna’s bivalent Covid vaccines for babies, in a move bound to draw criticism

Pre-school-aged children were already allowed to receive three extra-small doses of Pfizer’s original Covid vaccine, instead of the standard two-dose regimen for adults.

The move will see them given the Omicron-specific booster – made by either Pfizer of Moderna – as their third and final shot.

Officials recommend the children to receive the bivalent shot from the same brand they received their first two vaccine shots from.

So a child who receive the Pfizer vaccine for their first two doses should get the Pfizer bivalent shot as well. 

FDA Commissioner Robert Califf said: ‘More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine.

‘And we encourage parents and caregivers of those eligible to consider doing so – especially as we head into the holidays and winter months where more time will be spent indoors.

‘As this virus has changed, and immunity from previous COVID-19 vaccination wanes, the more people who keep up to date on COVID-19 vaccinations, the more benefit there will be for individuals, families and public health by helping prevent severe illnesses, hospitalizations, and deaths.’

The move comes despite the bivalent shots proving highly unpopular among even adult Americans.

Only 40million have received the shot – tailored specifically to the Omicron variant – which is the equivalent of 13 percent of the US population. 

The shots have been even less popular among parents with children under five. Only 9.3 percent of those aged two to four have received at least one vaccine dose, and 4.6 percent have completed their vaccine series.

For children under two, only 6.4 percent have gotten their primary shot and 2.7 percent all three.

Officials believe the new vaccine offers higher protection than the original vaccines that were designed for the first Covid strain out of Wuhan and got significantly weaker as the virus mutated.

Not many young children have received their Covid vaccines. Only 6.4 percent of children under two and 9.3 percent of those between two and four have received the first dose so far (yellow, left). Only 2.7 percent of children under two and 4.6 percent of those two to four have completed the three dose series (yellow, right)

Not many young children have received their Covid vaccines. Only 6.4 percent of children under two and 9.3 percent of those between two and four have received the first dose so far (yellow, left). Only 2.7 percent of children under two and 4.6 percent of those two to four have completed the three dose series (yellow, right)

Agency officials said they 'encourage parents and caregivers' to get their child vaccinated 'especially as we head into the holidays and winter months' (file)

Agency officials said they ‘encourage parents and caregivers’ to get their child vaccinated ‘especially as we head into the holidays and winter months’ (file) 

Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said: ‘Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death. 

‘Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19.

‘Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.’

Vaccine wars: Pfizer countersues rival Moderna after being accused of stealing its mRNA technology to create Covid vaccine — amid multi-billion-dollar legal battle 

Pfizer has countersued Moderna after being accused of stealing mRNA technology to create the Covid vaccine.

The ongoing legal battle now sees Pfizer and its partner BioNTech reject its rival’s claims it copied the shot.

Pfizer has accused Moderna of rewriting history, and dubbed its lawsuit ‘revisionist history’.

Manhattan-based Pfizer requested from a federal court in Boston that Moderna’s lawsuit be dismissed.

Pfizer and its German partner, BioNTech, fired back at Moderna on Monday in a patent lawsuit over their rival Covid-19 vaccines.

They are seeking dismissal of the lawsuit in Boston federal court and an order that Moderna’s patents are invalid and not infringed.

Moderna first sued Pfizer in August, when it accused the company of violating its rights in three patents related to innovations that Moderna said it pioneered before the Covid-19 pandemic.

Moderna has also filed a related lawsuit against Pfizer and BioNTech in Germany. All three companies are also embroiled in US patent disputes with other companies over the vaccines.

A Pfizer spokesperson said the company and BioNTech are confident in their intellectual property and will ‘vigorously defend’ against Moderna’s claims.

In its lawsuit, Moderna asked for an undisclosed amount of money damages from Pfizer Covid-19 vaccines sold since March.

Pfizer’s vaccine made over $26.4 billion for the New York-based company in the first nine months of 2022, according to company filings with the US Securities and Exchange Commission.

Meanwhile, Moderna sold over $13.5 billion worth of its vaccine over the same period.

Pfizer and BioNTech said in their Monday filing that they developed their vaccine independently, calling Moderna’s lawsuit ‘revisionist history’ and arguing its patents ‘far exceed its actual contributions to the field’.

The companies argued that Moderna ignored the contributions of their scientists to foundational mRNA technology, as well as those of researchers at the US government’s National Institutes of Health.

Moderna also waived its right to bring the lawsuit when it pledged not to sue other Covid-19 vaccine makers during the pandemic, the filing said, arguing the pandemic has not yet ended.

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Read more at DailyMail.co.uk



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