“R.itemList.length” “- this.config.text.ariaShown
“This.config.text.ariaFermé”
By Julie Steenhuysen
CHICAGO, July 31 (Reuters) – The first two COVID-19 vaccines to enter large-scale trials in the United States will not be tested on pregnant women this year, raising questions about how this vulnerable population will oppose coronavirus, researchers told Reuters.
Modern and Pfizer, which have partnered with BioNTech in Germany, this week introduced separate clinical trials using new and unproven genetic technology. Both corporations require evidence of negative pregnancy control and a commitment to use birth in the childbearing women component of being registered.
Drug brands say they will first need to make sure vaccines are and are more effective in general. In addition, U.S. regulators require drug brands to conduct ty studies on pregnant animals before vaccines are tested on pregnant women to ensure that they do not harm the fetus or cause miscarriage.
Specialists in bioethics, vaccines and maternal fitness have argued for years that pregnant women deserve to be included early in pandemic vaccine trials so that they do not have to wait long after the emergence of a successful candidate. This debate fell on deaf ears from the recent outbreaks of Ebola and Zika, but it gained new urgency in the COVID-19 era, as studies show that pregnant women are at increased risk of serious disease due to 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 American women were of childbearing age, reported as people over the age of 15 to 50. Currently, it is advised that pregnant women take flu and whooping cough vaccines and some others depending on individual circumstances, however, none of these vaccines have been particularly tested and shown for pregnant women.
“We have a lot of women of childbearing age who are likely to get pregnant, and what is the safest vaccine for them?” Said Dr. Larry Corey, an expert vaccine at the Fred Hutchinson Cancer Center in Seattle, who is helping oversee vaccine trials conducted through Moderna and other drug brands in collaboration with the U.S. government.
Doctors would possibly need to see even more knowledge about absolutely new vaccine technologies, such as those used through Moderna and Pfizer, compared to those already used in pregnant women.
These differences highlight why we “want vaccines” to more productively satisfy the desires of express populations, Corey said.
A PRECEDENT OF PREGNANCY
Johnson-Johnson, who this week presented a small-scale protection trial for his COVID-19 vaccine, uses the same underlying generation he used with his Ebola vaccine, which has been used in 1,000 pregnant women in the Democratic Republic of the Congo. More extensive studies are being conducted with this vaccine.
J-J’s clinical director, Dr. Paul Stoffels, told Reuters that the company had performed many years of “deep” preclinance with the Ebola vaccine, adding pregnant animals, and “saw no challenge.”
Stoffels said JJ would see in the coming weeks if he came with pregnant women in his gigantic Phase 3 Phase 3 trial for a COVID-19 vaccine, which is scheduled to begin in September.
Pfizer plans to begin toxicology studies on pregnant animals in the near future, with knowledge under review conditions through the U.S. Food and Drug Administration in the first trimester of 2021. Studies in pregnant women would likely begin some time later.
“We continue to explore possible tactics to shorten the time of studies in pregnant women,” Dr. Bill Gruber, senior vice president of vaccine studies and progression at Pfizer, told Reuters.
Of course, unplanned pregnancies can occur even when women use reliable contraception. Based on reports beyond these trials, Gruber said he expects about 1% of women participating in the Pfizer Phase 3 trial, or about 150 women, to become pregnant. And those women and their young children will be strictly monitored.
Moderna said in an email that the company submitted its pregnant animal protection exam last June and expects effects until the end of this year.
“Once we have generated additional knowledge about the protection of our vaccine, and have more often demonstrated its effectiveness, we intend to conduct further studies in this population,” said a Spokesperson for Moderna.
Sanofi, whose coronavirus vaccine is based on its influenza vaccine platform, is making reproductive toxicology in animals, however, these effects will not be in condition until the company’s primary Phase 3 trials begin, which are expected to begin until the end of the year.
Sanofi can identify a pregnancy record after approval of the vaccine to track results in pregnant women, as has been done in the past.
Merck and Co stated that it had still made a ruling on when to verify its vaccine candidate on pregnant women. Novavax and AstraZeneca Plc declined to comment.
Dr. Flor Muñoz, a specialist in the use of maternal vaccines at Baylor College of Medicine, said corporations have been reluctant to verify anything in pregnant women since the 1950s and 1960s, after the tymided drug, used to treat nausea pregnancy, caused widespread birth defects. She accepts that initial verification 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.” (Reporting by Julie Steenhuysen; editing by Michele Gershberg and Leslie Adler)