Health
First two large-scale U.S. COVID-19 vaccine trials will exclude pregnant women for now – The Globe and Mail
A nurse prepares a shot as the world’s biggest study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., gets underway in Binghamton, N.Y., on July 27, 2020.
Hans Pennink/The Associated Press
The first two COVID-19 vaccines to enter large-scale U.S. trials will not be tested in pregnant women this year, raising questions about how this vulnerable population will be protected from the coronavirus, researchers told Reuters.
Moderna and Pfizer, which has partnered with Germany’s BioNTech, this week separately launched clinical trials that use a new and unproven gene-based technology. Both companies are requiring proof of a negative pregnancy test and a commitment to using birth control from women of child-bearing age who enrol.
Drugmakers say they first need to make sure the vaccines are safe and effective more generally. In addition, U.S. regulators require that drugmakers conduct safety studies in pregnant animals before the vaccines are tested in pregnant women to ensure they don’t harm the fetus or lead to miscarriage.
Bioethicists, vaccine and maternal health experts have argued for years that pregnant women should be included early in trials of pandemic vaccines so they would not need to wait until long after a successful candidate emerges. That debate fell on deaf ears in recent outbreaks of Ebola and Zika, but has taken on new urgency in the era of COVID-19, as studies show pregnant women are at increased risk of severe disease from the new coronavirus.
“It’s a problem because if (vaccines) are not tested in pregnancy, then they may not be available or people may not be comfortable offering them,” said Dr. Denise Jamieson, chief of gynecology and obstetrics for Emory Healthcare in Atlanta.
According to the 2012 Census, 75.4 million U.S. women were of child-bearing age, defined as 15 to 50 years old. Currently, pregnant women are recommended to take flu and whooping cough vaccines and certain others depending on individual circumstances, but none of these have been specifically tested and proven safe for pregnant women.
“We have an enormous number of women of child-bearing age and potentially getting pregnant, and what’s the safest vaccine for them?” said Dr. Larry Corey, a vaccine expert at Fred Hutchinson Cancer Center in Seattle who is helping oversee vaccine trials conducted by Moderna and other drugmakers in collaboration with the U.S. government.
Doctors may want to see even more data for completely new vaccine technologies, such as those used by Moderna and Pfizer, compared with one that has already been used in pregnant women.
Such differences highlight why “we need multiple vaccines” to best address the needs of specific populations, Corey said.
A PRECEDENT IN PREGNANCY
Johnson & Johnson, which kicked off a small-scale safety trial for its COVID-19 vaccine this week, is using the same underlying technology that it used with its Ebola vaccine, which has been used in 1,000 pregnant women in Democratic Republic of Congo. Larger studies with that vaccine are now under way.
J&J’s chief scientific officer, Dr. Paul Stoffels, told Reuters the company has done many years of “extensive” preclinical study with the Ebola vaccine, including on pregnant animals, and “has not see any challenges.”
Stoffels said J&J would decide in the next few weeks whether it will include pregnant women in its large Phase 3 late-stage trial for a COVID-19 vaccine due to start in September.
Pfizer expects to start toxicology studies in pregnant animals shortly, with data ready for review by the U.S. Food and Drug Administration in the first quarter of 2021. Studies in pregnant women could start some time afterward.
“We continue to explore potential ways to shorten the time to studies in pregnant women,” Dr. Bill Gruber, Pfizer’s senior vice president of vaccine clinical research and development, told Reuters.
Of course, unplanned pregnancies can happen even when women are using reliable contraception. Based on past experiences in such trials, Gruber said he expects about 1 per cent of women in Pfizer’s Phase 3 trial, or about 150 women, will become pregnant. And those women and their babies will be followed closely.
Moderna said in an e-mailed statement that the company launched its safety study in pregnant animals at the end of June and expects results by the end of this year.
“Once we have generated additional safety data for our vaccine, and importantly demonstrated that it is efficacious, we intend to conduct additional studies in this important population,” a Moderna spokesperson said.
Sanofi, whose coronavirus vaccine is based on its flu vaccine platform, is doing reproductive toxicology in animals, but those results won’t be ready before the start of the company’s large Phase 3 trials, expected to start by year-end.
Sanofi may establish a pregnancy registry after the vaccine is approved to track outcomes in pregnant women, as has been done in the past.
Merck & Co said it has not made any decisions yet on when to test its vaccine candidate in pregnant women. Novavax and AstraZeneca Plc declined to comment on their plans.
Dr. Flor Munoz, an expert in maternal use of vaccines at Baylor College of Medicine, said companies have been reluctant to test anything in pregnant women since the 1950s and 60s, after the drug thalidomide, which was used to treat nausea in pregnancy, caused widespread birth defects. She agrees that preliminary testing is needed.
The vaccines “need to be reasonably safe and reasonably effective,” she said. “We don’t necessarily have to finish the Phase 3 trials.”
Hackers linked to China’s government targeted biotech company Moderna Inc, a leading U.S.-based coronavirus vaccine research developer, earlier this year in a bid to steal valuable data, according to a U.S. security official tracking Chinese hacking activity. Reuters
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Interior Health says it delivered nearly 800,000 immunization doses last year — a number almost equal to the region’s population.
The released figure of 784,980 comes during National Immunization Awareness Week, which runs April 22-30.
The health care organization, which serves a large area of around 820,000, says it’s using the occasion to boost vaccine rates even though there may be post-pandemic vaccine fatigue.
“This is a very important initiative because it ensures that communicable diseases stay away from a region,” said Dr. Silvina Mema of Interior Health.
However, not all those doses were for COVID; the tally includes childhood immunizations plus immunizations for adults.
But IHA said immunizations are down from the height of the pandemic, when COVID vaccines were rolled out, though it seems to be on par with previous pre-pandemic years.
Interior Health says it’d like to see the overall immunization rate rise.
“Certainly there are some folks who have decided a vaccine is not for them. And they have their reasons,” said Jonathan Spence, manager of communicable disease prevention and control at Interior Health.
“I think there’s a lot of people who are hesitant, but that’s just simply because they have questions.
“And that’s actually part of what we’re celebrating this week is those public health nurses, those pharmacists, who can answer questions and answer questions with really good information around immunization.”
Mima echoed that sentiment.
“We take immunization very seriously. It’s a science-based program that has saved countless lives across the world and eliminated diseases that were before a threat and now we don’t see them anymore,” she said.
“So immunization is very important.”
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The U.S. Food and Drug Administration said Tuesday that samples of pasteurized milk had tested positive for remnants of the bird flu virus that has infected dairy cows.
The agency stressed that the material is inactivated and that the findings “do not represent actual virus that may be a risk to consumers.” Officials added that they’re continuing to study the issue.
“To date, we have seen nothing that would change our assessment that the commercial milk supply is safe,” the FDA said in a statement.
The announcement comes nearly a month after an avian influenza virus that has sickened millions of wild and commercial birds in recent years was detected in dairy cows in at least eight states. The Agriculture Department says 33 herds have been affected to date.
FDA officials didn’t indicate how many samples they tested or where they were obtained. The agency has been evaluating milk during processing and from grocery stores, officials said. Results of additional tests are expected in “the next few days to weeks.”
The PCR lab test the FDA used would have detected viral genetic material even after live virus was killed by pasteurization, or heat treatment, said Lee-Ann Jaykus, an emeritus food microbiologist and virologist at North Carolina State University
“There is no evidence to date that this is infectious virus and the FDA is following up on that,” Jaykus said.
Officials with the FDA and the USDA had previously said milk from affected cattle did not enter the commercial supply. Milk from sick animals is supposed to be diverted and destroyed. Federal regulations require milk that enters interstate commerce to be pasteurized.
Because the detection of the bird flu virus known as Type A H5N1 in dairy cattle is new and the situation is evolving, no studies on the effects of pasteurization on the virus have been completed, FDA officials said. But past research shows that pasteurization is “very likely” to inactivate heat-sensitive viruses like H5N1, the agency added.
Matt Herrick, a spokesman for the International Dairy Foods Association, said that time and temperature regulations for pasteurization ensure that the commercial U.S. milk supply is safe. Remnants of the virus “have zero impact on human health,” he wrote in an email.
Scientists confirmed the H5N1 virus in dairy cows in March after weeks of reports that cows in Texas were suffering from a mysterious malady. The cows were lethargic and saw a dramatic reduction in milk production. Although the H5N1 virus is lethal to commercial poultry, most infected cattle seem to recover within two weeks, experts said.
To date, two people in U.S. have been infected with bird flu. A Texas dairy worker who was in close contact with an infected cow recently developed a mild eye infection and has recovered. In 2022, a prison inmate in a work program caught it while killing infected birds at a Colorado poultry farm. His only symptom was fatigue, and he recovered.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
Canada is about where it should be when it comes to childhood vaccines, but for adult vaccinations it’s a different story.
Dr. Vivien Brown of Immunize Canada says the overall population should have rates of between 80 and 90 per cent for most vaccines, but that is not the case.
She says most children are in that range but not for adult vaccines and ultimately the most at-risk populations are not being reached.
She says the population is under immunized for conditions such as pneumonia, shingles, tetanus, and pertussis.
Brown wants people to talk with their family physician or pharmacist to see if they are up-to-date on vaccines, and to get caught up because many are “killer diseases.”
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