The risk of severe covid-19 is particularly acute in the third trimester and raises the prospect of prematurity and stillbirth. It also raises the possibility of long-term health problems.

Early clinical trials of covid-19 vaccines excluded a large number of pregnant women, but also, they themselves walked away from the trials because they were confronted with confusing messages and misinformation about the dangers to their unborn children.

For example, outside, in Britain about 75% and in the United States (65%) of pregnant women to date have not been vaccinated. Thus, this demographic group is placed among those most at risk of infection and exposed to severe forms of the disease as the rapidly spreading omicron strain spreads around the world.

At least 17 pregnant women and four babies died from covid-19 in England between May and October, according to data published last week. During that period, 98% of pregnant women admitted to intensive care were not vaccinated.

In addition, as of July, one in five covid-19 patients receiving treatment in that nation through a special lung bypass machine was an unvaccinated mother-to-be.

"The uptake of vaccination in pregnant women is depressing and a significant number of women have suffered serious harm as a result," said the UK's chief medical adviser, Dr. Chris Whitty. "Pregnancy is a period of vulnerability. We should have made this point even clearer earlier."

There is little information about this group of people. While worldwide data has shown that vaccines are safe and effective for most ordinary people, the absence of pregnant women in early vaccine trials has resulted in a hesitancy that is hard to shake.

Vaccine hesitancy complicates the immunocompromised state caused in pregnant women by their bodies' efforts to make the fetus develop. The risk of severe covid-19 is particularly acute in the third trimester and raises the prospect of prematurity and stillbirth. It also raises the possibility of long-term health problems for the pregnant woman.

Many maternal care experts have seen this happen, said Dr. Pat O'Brien, vice president of the Royal College of Obstetricians and Gynaecologists.

"We were concerned from day one that it might be worse in pregnant women than in other people, because other respiratory viruses have been, like Sars and influenza," he said, suggesting that women should be included in vaccination processes "when it is safe to do so at an early stage in all trials of new drugs and vaccines."

At least one junkie tried it. In February, Pfizer began a mid-stage trial in pregnant women before moving to advanced testing in June.

But low enrollment and the ethical dilemma of giving pregnant women placebos when vaccines had already been recommended caused the trial to be stopped with less than 10% of its target, 4,000 volunteers.

"I think this has opened the eyes and the potential for regulators and manufacturers to start pregnancy studies earlier," said Pfizer's vice president of vaccine research and development, Dr. Alejandra Gurtman.

The problem is deciding what is a better time to include pregnant women. Vaccines must be demonstrated to be safe in the general population before authorities can expose unborn children.

"If we were not in such an 'all-out' pandemic mode, we probably could have started a trial earlier in pregnant women," said US Food and Drug Administration vaccine program chief Dr. Peter Marks.

"If I were drafting this from scratch again, probably within a few months after we received the safety data from the phase three clinical trials, we probably could have started a trial in pregnant women," he said.

Some of the reticence comes from history. Although not a vaccine, in the 1950s a drug called thalidomide was prescribed for nausea of early pregnancy. It severely affected limb development in children and affected more than 10,000 babies, half of whom died.

A lack of information about vaccine safety in the first trimester and an excess of misinformation on social media, especially about the impact vaccines could have on a growing baby and fertility, have not helped.

Recall that one "news" went so far as to suggest vaccines caused miscarriages.

Dr. Laura Magee, an obstetrician in Britain, said that the similarity between a protein in the developing placenta and the virus spike protein raised concerns that antibodies from the vaccine might attack the placenta, although studies have shown that this is not the case.

"There is no basis for any concern that the antibodies that are produced as a result of vaccination acceptance will interfere with placental development," she said.

Clinical trials have also shown that the vaccines had no impact on fertility. The same is true for birth outcomes, stillbirths (stillbirths) or low birth weights, according to data from the UK Health Security Agency.

Such assurances failed to make a big difference, suggesting the need for better communication and earlier involvement of pregnant women.

The British drug regulator says it is looking into "how developers of new drugs and vaccines could improve the inclusion of pregnant women in studies." One way would be to start trials when early trials have established safety and advanced trials are underway, as Pfizer did with teenage girls.

For Dr. Ruth Faden, a bioethicist at Johns Hopkins who is involved in the Prevent working group, - which has drafted guidance on vaccines in epidemics and pregnant women in 2019 - covid-19 shows why a serious rethink is needed.

"The experience of this pandemic, which went so badly for pregnant women. I am hopeful that it will be enough to at least in the epidemic-vaccine space to result in some changes in the future," he said.

Source: straitstimes