Two studies to examine safety of COVID vaccine for pregnant and breastfeeding women

Two studies to examine safety of COVID vaccine for pregnant and breastfeeding women

Canadian researchers are examining the safety and effectiveness of COVID-19 vaccines among pregnant and breastfeeding women, as well as the health of mothers and their babies in the case of pregnant women who were immunized or not.

One national study led by researchers in British Columbia is looking at women’s attitudes toward vaccination as well information on other health factors and adverse effects from immunization and how a pregnancy has proceeded.

A second study in Ontario is monitoring the health of mothers and their babies as researchers compare people who were vaccinated during pregnancy, or just before, with those who were not immunized.

Both studies, with $1.3 million in federal funding, are aimed at giving women, health-care providers and provincial vaccine advisory committees the data they need to guide decisions and recommendations about vaccines.

Dr. Deborah Money, who is leading the national study, said women will answer questions in a series of modules to provide information on whether they were vaccinated, received one dose or two doses, and if they were infected with COVID-19 so outcomes can be compared among all the participants.

She said that while pregnant and breastfeeding women were excluded from initial clinical trials on vaccines, real-world evidence suggests immunization is safe during pregnancy and further studies are needed specifically for Canada’s population.

“There are a couple of small studies that the vaccine companies are running, none of which are in Canada yet, to my knowledge, that are including pregnant women,” said Money. “But they’re having difficulty because the vaccine essentially has rolled out for pregnant women already and they can’t run their usual placebo-controlled trials ethically.”

Money, a professor in the department of obstetrics and gynecology at the University of British Columbia, said about 4,000 women have already registered in the study and she’s inviting people from across the country to participate.

Data from a different ongoing national study led by Money suggests pregnant women are at a significantly higher risk of being hospitalized and ending up in intensive care and on a ventilator compared with the general population in their age group due to changes in immune response during pregnancy.

“There are also physiologic changes of pregnancy that seem to result in more susceptibility to more serious respiratory infections and we saw that actually with H1N1 and other flu pandemics that pregnant women got more seriously ill,” she said.

The Society of Obstetricians and Gynecologists of Canada as well as a national vaccine advisory panel have recommended vaccines for women who are pregnant or breastfeeding and several provinces, including B.C., Ontario, Saskatchewan, Manitoba, Quebec and New Brunswick have prioritized pregnant women for immunization.

The Ontario-based study will link information collected from all births in that province since last December, when vaccines became available, with Ontario’s vaccination registry to monitor the health of mothers and their babies.

Lead researcher Dr. Deshayne Fell, a scientist at the CHEO Research Institute and associate professor at the University of Ottawa, said the data will be made available on an ongoing basis during the estimated two-year study period so women can make informed decisions about vaccination.

“I think it’s terrible for anybody to be so severely ill that they’re in an ICU and ventilated. It’s much more complicated to have that kind of clinical disease severity in a pregnant person, so with ventilation and pregnancy it’s really complex,” she said. “Care providers are concerned about the welfare of their patients and obviously you want to make sure that pregnant women at least have the opportunity to be protected.”

Some international studies have found that a mother’s vaccine-induced immunity can transfer to her infant, similar to what’s been seen with the influenza and pertussis or whooping cough vaccines, both of which are routinely recommended to pregnant women, said Fell, who is also involved in the new study led by Money.

Fell said that while the Centers for Disease Control and Prevention in the United States has released some data on vaccines and pregnancy, differences in the Canadian population, including racial ethnicity composition, underscore the need for studies in Canada.

“Our health-care system is different and pregnancy outcomes are a little bit different. For instance, in the United States, they have slightly higher rates of preterm birth than we tend to have here in Canada. Just the whole dynamics of the pandemic itself are very different here.”

About 6,035 pregnant women in Canada have been infected with COVID-19 based on data to the end of April, and about 95 women ended up in hospital across the country, though up-to-date information from Quebec and Saskatchewan is not available, Fell said.

Studies from around the world suggest pregnant women who were admitted to hospital or required ventilation due to COVID-19 infection tended to have babies earlier and thatthose babies were smaller in size than those of their healthy counterparts, she said.

Some research also found a higher risk of stillbirth with a COVID-19 infection during pregnancy, she added.

This report by The Canadian Press was first published May 19, 2021.

Camille Bains, The Canadian Press


Just Posted

A small selection of shoes line a step at the municipal government building in Sylvan Lake, with each pair representing a vicitm of residential schools in Canada. Tracey Greinke placed the first pair of shoes on the steps, hoping more would follow. (Photo by Megan Roth/Black Press news services)
Sylvan Lake woman sets up small memorial for residential school victims

Tracey Grienke placed a pair of moccasins on the steps of town hall, and a few more followed

A section of the eastern slopes south west of Longview, Alta., Wednesday, June 16, 2021. A new report finds big differences in how different governments have responded to Canada’s promise to increase the amount of land it protects. THE CANADIAN PRESS/Jeff McIntosh
A for Quebec, F for Alberta: Study rates Canadian governments on conservation

Report by the Canadian Parks and Wilderness Society

Russian President Vladimir Putin attends a ceremony in memory of those killed during WWII as he takes part in a wreath laying ceremony at the Tomb of Unknown Soldier in Moscow, Russia, Tuesday, June 22, 2021, marking the 80th anniversary of the Nazi invasion of the Soviet Union. (Alexei Nikolsky, Sputnik, Kremlin Pool Photo via AP)
Putin hails WWII heroes, warns of degrading Europe security

Kremlin anxious to see international recognition of wartime sacrifices and its role in defeating Nazis

FILE - In this May 19, 2021, file photo, mice scurry around stored grain on a farm near Tottenham, Australia. A mouse plague that has ravaged vast swathes of eastern Australia has forced the evacuation of a prison while authorities repair gnawed electrical wiring and clear dead and decaying mice from wall cavities and ceilings, Corrective Services Commissioner Peter Severin said on Tuesday, June 22, 2021. (AP Photo/Rick Rycroft, File)
Australian prison to be evacuated after mice move in

Plagues usually happen when rain follows several years of drought

European Union foreign policy chief Josep Borrell looks at his papers as Belarusian opposition politician Sviatlana Tsikhanouskaya, background left, talks to Cypriot Foreign Minister Nicos Christodoulides during a European Foreign Affairs Ministers meeting at the European Council building in Luxembourg, Monday, June 21, 2021. EU foreign ministers were set to approve Monday a new set of sanctions against scores of officials in Belarus and prepare a series of measures aimed at the country’s economy. (Johanna Geron/Pool Photo via AP)
EU, US, UK, Canada join forces to slap sanctions on Belarus

Asset freezes and travel bans also imposed

Black Horse Singers performed for students at Ecole la Prairie on Monday. (Photo by SUSAN ZIELINSKI/Advocate staff)
WATCH: Students remind Red Deer that every child matters on National Indigenous Day

Heart-shaped messages to decorate trees at Ecole la Prairie through the summer

FILE - Canada’s Cyle Larin (17) scores past Haiti’s Josue Duverger, bottom left, during the second half of a World Cup qualifying soccer match Tuesday, June 15, 2021, in Bridgeview, Ill. (AP Photo/Kamil Krzaczynski)
Toronto FC’s Zavaleta wastes little time settling in with El Salvador national team

Indiana-born Zavaleta qualifies for El Salvador through his father

Summer McIntosh swims her way to first place in the Women’s 800m Freestyle at the 2020 Olympic Swimming Trials in Toronto, Monday, June 21, 2021. McIntosh, who edged Rio Olympic star Penny Oleksiak in the 200-metre freestyle final a day earlier, picked up where she left off in the women’s 800-metre freestyle. THE CANADIAN PRESS/Frank Gunn
Summer Time: 14-year-old McIntosh wins again at Olympic swim trials

McIntosh will be one of the youngest athletes in Tokyo

This undated photo provided by Walt Disney World shows Disney characters at Walt Disney World in Lake Buena Vista, Fla. Walt Disney World is planning an 18-month celebration in honor of its 50th anniversary, starting in October 2021. Disney announced Tuesday, June 22 that all four parks at the resort will take part in “The World’s Most Magical Celebration.” (Matt Stroshane/Walt Disney World via AP)
Walt Disney World’s 50th anniversary party starts Oct. 1

Favorite Disney characters will be part of a collection of special golden sculptures at all four parks

Columnist Treena Mielke
Family: When rain cancels ball game

The wild roses are out, blooming in roadside ditches, their gentle beauty… Continue reading

Tampa Bay Lightning center Tyler Johnson, center, tries to get position for a shot against New York Islanders goaltender Ilya Sorokin (30) during the second period in Game 5 of an NHL hockey Stanley Cup semifinal playoff series Monday, June 21, 2021, in Tampa, Fla. (AP Photo/Chris O'Meara)
Stamkos, Vasilevskiy pace Lightning’s 8-0 rout of Islanders

Lightning 8 Islanders 0 (Tampa Bay leads series 3-2) TAMPA, Fla. —… Continue reading

Calgary Mayor Naheed Nenshi says he’s ‘convinced’ the city will be able to get rid of the mandatory mask bylaw in July. (File photo by THE CANADIAN PRESS)
‘Made in Calgary’ approach will keep mask requirements past Alberta’s total reopening

Calgary won’t be following provincial recommendations on the mandatory wearing of masks… Continue reading

Most Read