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Study Will Test Different Time Intervals for COVID-19 Vaccines in Pregnant Individuals – Technology Networks

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A new UK-based clinical trial will test the most appropriate time interval between two doses of an mRNA COVID-19 vaccine in pregnant individuals. 

COVID-19 vaccines and pregnancy


In 2020, clinical trials of COVID-19 vaccines now authorized for human use did not include pregnant or breastfeeding individuals. This approach is typical for the clinical study of a new investigational medicinal product and is enforced by regulatory bodies such as the US Food and Drug Administration (FDA) to protect both mothers and pregnancies.

As the global rollout of several COVID-19 vaccines commenced, many pregnant individuals opted to be immunized against SARS-CoV-2 regardless. This enabled scientists to gather real-world retrospective data on the safety and efficacy of the different types of vaccines in this population. Based on the growing data supply, in April, the UK’s Joint Committee on Vaccination and Immunisation (JCVI) advised that pregnant persons in the UK should be offered two doses of mRNA-based vaccines (Pfizer–BioNTech’s BNT162b2 or Moderna’s mRNA-1273) where available.

However, data gaps remain,  Professor of Pediatric Infectious Diseases Paul Heath from St George’s University of London explained in a recent press release: “Tens of thousands of pregnant women have now been vaccinated in both the US and the UK with no safety concerns reported, but we still lack robust, prospective clinical trial data on COVID-19 vaccines in pregnant women.”

More information is required to determine the best time schedule for administering the two mRNA COVID-19 vaccine doses in pregnant individuals in order to achieve the optimum immune response. A new study led by Heath – known as Preg-Cov – will provide this vital clinical information.

Vaccine dose intervals in pregnancy


Preg-Cov will recruit over 600 low-risk pregnant women aged 18-45-years-old across a number of sites in the UK. All participants will receive two doses of an mRNA-based COVID-19 vaccine (either Pfizer–BioNTech’s BNT162b2 or Moderna’s mRNA-1273). The eligibility criteria permits the inclusion of individuals that have received their first dose prior to enrolling in the trial. Speaking to Technology Networks, Heath said: “All will be blinded to the COVID-19 vaccine they receive except for the group that have received a dose before pregnancy – as they obviously know what they had already.”

Participants must be between 13 and 34 weeks pregnant on the date of the first COVID-19 vaccination, and will be divided into two groups: short interval and long interval dosing. The short interval group will receive their second COVID-19 vaccine between four to six weeks after their first dose, whereas the long interval group will receive their second dose between 8 and 12 weeks after their first. Consequently, some individuals will receive their second dose after delivering their baby. The study will follow all recruits for a period of one year.

“It’s important to highlight that all participants in this study will receive a COVID-19 vaccine. This is particularly important with the rising number of cases, the easing of restrictions and low vaccine uptake among pregnant women,” Professor Asma Khalil, lead obstetrician for the trial said.

Throughout the duration of the trial, various data will be collected. Recruits will be asked to maintain a symptom diary and blood samples will be obtained from the mother. In some instances, cord blood will also be extracted. “The blood samples are taken from all mothers but cord blood only from mothers at certain sites. This is because we don’t actually need to take as many samples to address the question about transfer of antibody from mother to baby in the cord blood,” Heath told Technology Networks.

The trial – which is now open for enrollment – is supported by £7.5 million worth of funding from the UK government. “Pregnant women are more likely to get seriously ill from COVID-19 and we know that vaccines are safe for them and make a huge difference – in fact no pregnant woman with two jabs has required hospitalisation with COVID-19,” said the Minister for Covid-19 Vaccine Deployment, Nadhim Zahawi. “This government-backed trial will provide more data about how we can best protect pregnant women and their babies, and we can use this evidence to inform future vaccination programmes.”

Professor Paul Heath was speaking to Molly Campbell, Science Writer for Technology Networks. 

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More than half of Manitoba's 64 new COVID-19 cases unvaccinated – CTV News Winnipeg

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WINNIPEG –

While more than half of Manitoba’s new COVID-19 cases are among the unvaccinated, the province reported 20 breakthrough infections.

On Thursday, Manitoba public health officials reported 64 new COVID-19 cases – including 36 unvaccinated cases and eight partially vaccinated cases. Twenty of the cases were among people who had been fully vaccinated.

“No vaccine is 100 per cent effective. However, people who are fully vaccinated typically have a better outcome than individuals who are not vaccinated,” a spokesperson told CTV News in an emailed statement.

“Public health continues to recommend that the best defence against COVID-19 is to get immunized.”

As of Thursday, 84 per cent of eligible Manitobans have rolled up their sleeve for at least one dose of a COVID-19 vaccine. Seventy-nine per cent of eligible Manitobans are vaccinated with two doses.

The spokesperson said while breakthrough cases can occur, the outcomes are typically not as severe as they are for non-vaccinated individuals. They said fully vaccinated people who get infected typically do not need to go to ICU.

As of Thursday, 62 people in Manitoba are in hospital with COVID-19, including 26 people who have active cases. Of those active cases, 20 are not vaccinated, four are partially vaccinated and two are fully vaccinated.

There are five people in the intensive care unit with active cases of COVID-19, all of whom are unvaccinated.

Data from the province obtained by CTV News shows there have been 728 infections and 16 deaths among the 915,200 people fully immunized in the province.

Of the 986,054 people who have been partially immunized in Manitoba, the data shows there have been 2,215 infections and 45 deaths.

The Southern Health region saw the most cases in the province on Thursday, with 23 new cases reported.

The Northern and Winnipeg health regions both reported 15 new cases. Winnipeg is sitting with a 1.2 per cent five-day test positivity rate.

The Prairie Mountain Health Region reported six new cases and the Interlake-Eastern health region reported five new cases.

The new cases bring Manitoba’s total to 59,526, including 599 active cases and 57,724 recoveries. Seven cases were removed from the total due to data corrections.

The provincial five-day test positivity rate is now 2.5 per cent.

The province also released some details of two deaths that were announced on Wednesday – both of which were linked to variants of concern. The deaths include a woman in her 70s from the Interlake-Eastern health region, linked to the Delta variant, and a man in his 80s from Winnipeg linked to an unspecified variant.

The total number of people who have died with COVID-19 sits at 1,203, including 201 deaths that have been linked to variants of concern.

In total, Manitoba has linked 18,065 cases to variants. 370 variant cases are active, and 17,494 have recovered.

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Goodbye Pfizer, hello Comirnaty: top COVID-19 vaccines renamed in Canada – KitchenerToday.com

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It’s pronounced koh-MIHR’-nuh-tee. Never heard of it? Well, get used to it. It’s what Canada will be calling the Pfizer vaccine from now on, at least officially.

Health Canada has approved new monikers for Pfizer, Moderna and Oxford-AstraZeneca vaccines and announced the change on social media today.

The Pfizer-BioNTech vaccine has now been dubbed Comirnaty, which the company says represents a combination of the terms COVID-19, mRNA, community, and immunity.

The Moderna vaccine will go by SpikeVax and the AstraZeneca vaccine will be named Vaxzevria.

Pfizer and Moderna say the change marks the full approval of the vaccines by Health Canada, which were previously approved under an interim order that was set to expire today.

During the interim order, the vaccines didn’t go by their brand names, but now that new and more long-term data has been submitted and approved they will go by their permanent name.

“Health Canada’s approval of COMIRNATY for individuals ages 12 and older affirms the vaccine’s safety and efficacy shown in longer term data submitted to Health Canada — and hopefully that licensure may improve vaccine confidence among Canadians,” Pfizer spokesperson Christina Antoniou wrote in a statement.

It’s the first time SpikeVax, until now known as the Moderna vaccine, has been fully approved anywhere in the world, Stéphane Bancel, the company’s CEO, said in a press release Thursday.

Health Canada points out the vaccines themselves are not changing — only the names are.

Although the name change has been approved, Canada will still receive vials labelled Pfizier-BioNTech for the next several months.

The FDA approved new names in the United States earlier this summer, and the vaccines have been going by their brand names in the EU since the spring.

Story by Laura Osman, The Canadian Press

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How concerning is the latest COVID-19 Mu variant in B.C.? – News 1130

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VANCOUVER (NEWS 1130) — A new strain of the COVID-19 virus is now in the province, and it is leading to questions around potential risk.

The B.1.621 — or Mu — variant was first discovered in Colombia in January and has been found in more than 40 people in B.C. since June. The World Health Organization has now classified the strain as a “Variant of Interest.”

The case numbers are minimal compared to the highly transmissive Delta variant, which has exploded across the country, leading to more COVID-19 cases and hospitalizations.

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In B.C. alone, nearly all the new cases of COVID-19 are linked to the Delta variant.

Still, there was a time when the impact of that strain was not known, prompting many to worry that the new Mu variant could be just as dangerous as Delta.

Sally Otto, a UBC zoology professor and modelling researcher, says right now, that’s not the case and there is no need to panic.

“Mu hasn’t actually been rising in frequency, it’s been kind of hovering under about two per cent frequency, relative to what we saw with Delta, which was once it got established, [there was] really rapid exponential growth,” Otto said.

“That doesn’t mean we shouldn’t pay attention to it, we absolutely should keep an eye on it. But it’s not taking off. Right now, Delta is the main player, the main variant that is the most transmissible and the most worrisome in this country,” Otto said.

Dr. Birinder Narang, co-founder of This is Our Shot campaign, agrees. “It is not showing a significant impact in B.C., we need to watch,” he wrote on social media.

The bigger concern than the variant itself, Otto says, is how slow Canada is at sharing data from mapping virus sequences to discover variants of interest present in the population.

A new report found Canada among the worst for sharing data on genome sequencing.

Canada takes three months to present collected data to the global database, compared to the United Kingdom which is able to do it in just two weeks.

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The data is then studied by public health officials, scientists, and other experts around the world to examine what variants are present, and how fast they are spreading.

“There could absolutely be more variants. Now to be honest, Canada doesn’t have as much cases as there are globally so the chances are the variant of concern is going to arise somewhere else. But if a variant of concern arises in Canada, we can’t tell.”

She says the delay in information impacts making real-time decisions on public policy surrounding the virus.

“We can’t tell within Canada if there are subtypes of the Delta that are spreading faster than others, and that’s something we need to know,” she said about the mutations and which ones to pay attention to.

Otto says the disconnect of information sharing is even happening in Canada between provinces and territories.

“Here in British Columbia we are sequencing almost every single case of COVID to try and identify what exactly the genetic changes are inside the genome of the virus. But unfortunately that is not then being shared globally, and it’s not even being shared across Canada. And that means that scientists like me who aren’t inside the public health office, we can’t use our skills to look for the changes that are happening in these genomes,” she said, adding the last time B.C. updated their data was two months ago.

Despite fears, the BC Centre of Disease Control says the current vaccines protect against all variants of concern, including Delta, and because variants spread more easily, it is even more important for the majority of the population to be vaccinated.

“This helps protect people who cannot get vaccinated, including children under 12,” the BCCDC explained.

With files from Nikitha Martin

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