babies

Pfizer Set to Seek Approval for Its Covid Vaccine in U.S. Babies This Winter

It’s been less than a week since reports suggested Pfizer was preparing to seek approval from U.S. and European medicines agencies for its vaccine in 5-11 year-olds. The pharmaceutical is now seeking authorisation for the vaccination of American babies as young as six months this winter. MailOnline has the story.

In a move likely to cause international controversy, the company intends to apply for authorisation to immunise American infants within the next two months.

The timeline will depend on the findings of in-house trials looking into whether the vaccines are safe and effective in youngsters aged six months to five years.

Frank D’Amelio, Chief Financial Officer at Pfizer, told an industry conference yesterday that the firm plans to “go file” by November, the Financial Times reports.

“We would expect to have… data for children between the ages of six months and five years old that we would file with the FDA,” D’Amelio said at the Morgan Stanley Global Healthcare Conference. “I’ll call it in the weeks shortly thereafter the filing of the data for the five to 11 year-olds.”

Pfizer was already planning to seek approval from the Food and Drug Administration (FDA) for the jabs to be given in children aged five to 11 by October.

But the latest comments confirm the firm’s intention to work its way down much younger age groups. They will be given a lower dose than adults. …

Scott Gottlieb, who headed the FDA under former President Donald Trump and now sits on the board of directors at Pfizer, says that the emergency use approval process for vaccinating young children could be done in a matter of weeks.

Gottlieb says the pharmaceutical giant is expected to file the paperwork with the federal government requesting authorisation to vaccinate kids as early as September.

Worth reading in full.

Children Born During Lockdown Have Significantly Reduced Verbal, Motor and Overall Cognitive Performance

Children born over the past year of lockdowns – at a time when the Government has prevented babies from seeing elderly relatives and other extended family members, from socialising at parks or with the children of their parent’s friends, and from studying the expressions on the faces behind the masks of locals in indoor public spaces – have significantly reduced verbal, motor and overall cognitive performance compared to children born before, according to a new U.S. study. Tests on early learning, verbal development and non-verbal development all produced results that were far behind those from the years preceding the lockdowns.

Impact of the Covid Pandemic on Early Child Cognitive Development: Initial Findings in a Longitudinal Observational Study of Child Health.

The Guardian has more.

With limited stimulation at home and less interaction with the world outside, pandemic-era children appear to have scored shockingly low on tests designed to assess cognitive development, said lead study author Sean Deoni, Associate Professor of Paediatrics (Research) at Brown University.

In the decade preceding the pandemic, the mean IQ score on standardised tests for children aged between three months and three years of age hovered around 100, but for children born during the pandemic that number tumbled to 78, according to the analysis, which is yet to be peer-reviewed. …

The study included 672 children from the state of Rhode Island. Of these, 188 were born after July 2020 and 308 were born prior to January 2019, while 176 were born between January 2019 and March 2020. The children included in the study were born full-term, had no developmental disabilities and were mostly white.

Those from lower socioeconomic backgrounds fared worse in the tests, the researchers found.

The biggest reason behind the falling scores is likely the lack of stimulation and interaction at home, said Deoni. “Parents are stressed and frazzled… that interaction the child would normally get has decreased substantially.”

Whether these lower cognitive scores will have a long-term impact is unclear. In the first few years of life, the foundations for cognition are laid, much like building a house – it’s easier to add rooms or flourishes when you’re building the foundation, Deoni said. “The ability to course-correct becomes smaller, the older that child gets.”

Given this data comes from a relatively affluent part of the U.S., where social support and unemployment benefits are generous, the fear is that things could be worse in poorer parts of the country and the world, he added.

Worth reading in full.

Stop Press: Lockdown enthusiast Stuart Ritchie is sceptical about these findings.

Preg-CoV: New Trial to Study Potential Side-Effects of Covid Vaccination on Pregnant Women on Babies

A new clinical trial based in the U.K. will seek to determine the most suitable gap between the first and second Covid vaccine jabs for pregnant women, as well as the potential side effects on their unborn children. Those running the trial hope it will make pregnant women feel more comfortable about getting vaccinated. The Guardian has the story.

Last week, Professor Jacqueline Dunkley-Bent, Chief Midwifery Officer for England, urged expectant mothers to get vaccinated as soon as possible, with evidence suggesting the Delta variant poses a significantly greater risk to pregnant women than previous forms of the virus.

A clinical trial called Preg-CoV has been launched to help determine the best gap between doses for pregnant women as well as exploring in greater detail potential side-effects and the impact on babies – something the researchers hope will offer reassurance. …

Asma Khalil, Lead Obstetrician for the trial and Professor of Obstetrics and Maternal Fetal Medicine at St George’s, said that while the U.K. Covid vaccination programme had been a success, uptake has been low among pregnant women.

According to research in her own hospital, “among pregnant women who’ve given birth between March this year until beginning of July, less than one third – 28% – of women who were eligible according to the guidance actually received [at least one dose of] the Covid vaccine” during pregnancy, said Khalil. …

“Pregnant women are still concerned because pregnant women were not included in initial Covid vaccine trials,” said Khalil.

In the first phase of the Preg-CoV trial, the team hope to recruit 600 pregnant women, aged between 18 and 44, from 13 sites across England.

Two groups of 200 unvaccinated pregnant women at different gestation times will be randomised both with respect to whether they receive a Moderna or Pfizer/Biontech jab and to whether they are given their second dose four to six weeks or at eight-12 weeks after the first dose. 

Participants will not know which Covid jab they are given… while a routine vaccination to protect against whooping cough will also be included in the schedule so that participants are not aware which dosing regime they are following.

A third group of about 100 pregnant women will be given one dose of a Covid jab at 28-34 weeks gestation, with the second dose of the same vaccine given after delivery, while the fourth group of 100 women will already have had their first dose of any Covid jab before or very early in pregnancy and will get the second dose of the same vaccine.

All the women will have follow-up visits and blood tests, and fill in an electronic diary to help the researchers monitor any potential vaccine side-effects. The team will also track outcomes for the babies up to 12 months of age to explore safety and impact on their development. …

“I think there will be some lessons learned from this pandemic,” said Khalil. “And one of them is that we should consider including pregnant woman at a relatively early stage for vaccine trials.”

Worth reading in full.