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Pregnant women in the US are unlikely to be given coronavirus vaccines until next year

NEWSDOS by NEWSDOS
December 11, 2020
Reading Time: 13 mins read
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Pregnant women in the US are unlikely to be given coronavirus vaccines until next year

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Pregnant women in the US will likely have to wait to receive the coronavirus vaccine from Pfizer Inc. after it was approved by the Food and Drug Administration (FDA).

Data from the Centers for Disease Control and Prevention (CDC) shows that pregnant COVID-19 patients are twice as likely to be admitted to intensive care units and three times more likely to require mechanical ventilation than non-pregnant women with the disease.

In addition, expectant mothers are twice as likely to die as women who are not carrying babies.

However, to date, vaccine studies have not been conducted in pregnant women – and this is not expected to happen until after the first quarter of 2021 – which means no safety data are available.

The researchers want to find out if the vaccines are safe and effective in healthy, non-pregnant people before testing them on expectant mothers and their future children.

The study’s scientists also want to see if female participants became pregnant during the vaccine studies, so they can see early on how the shot is behaving.

This comes after the UK Medicines and Health Products Regulatory Agency (MHRA) issued guidelines clarifying that pregnant women should not be vaccinated until after they are born.

The FDA is unlikely to include pregnant women in groups who can receive the Pfizer coronavirus vaccine once it's approved (file image).

The FDA is unlikely to include pregnant women in groups who can receive the Pfizer coronavirus vaccine once it’s approved (file image).

During the meeting of the FDA’s advisory committee to recommend whether or not to approve Pfizer, the researchers found that 23 pregnancies had occurred as of November 14.

Of the pregnancies, 12 occurred in the vaccine group and 11 in the placebo group.

In the vaccine group, four were immunized before their last menstrual period, four within 30 days of their last menstrual period, and four more than 30 days after.

In the placebo group, two weeks were vaccinated before their last menstrual period, six within 30 days of their last menstrual period and two more than 30 days afterwards.

Other than one woman in the placebo group who had a miscarriage in less than 20 weeks of pregnancy, no results are known.

It is not uncommon not to include pregnant women in vaccine studies.

For example, expectant mothers were never included in flu prevention studies, but encouraged by doctors to get them after years of data showing that the bite behaved normally in healthy participants.

However, doctors say they are concerned because the workforce is made up of millions of pregnant or breastfeeding women.

According to the CDC, 75 percent of health care workers are female, and approximately 330,000 health care workers could be “pregnant or recently given birth” at the time of vaccine implementation.

Recently, the Society for Maternal-Fetal Medicine called on the federal government to include pregnant and breastfeeding women in vaccine studies.

And in a statement in STAT News, three Johns Hopkins professors urged the FDA to allow pregnant or postpartum health care workers to get the shot.

“We disagree with the position of the UK authorities that it may be impossible for pregnant or breastfeeding health workers to get the vaccine regardless of their circumstances,” they wrote.

“If we cannot provide vaccines to frontline health workers who are pregnant or breastfeeding, it is up to health systems to provide them with alternative protection strategies such as shielding, reassignment, or paid leave.

“However, this may not be a viable strategy for most healthcare facilities that cannot afford to work without a significant portion of their workforce.”

However, the UK government has urged pregnant women not to receive any vaccine that has been or may be approved, including those made by Pfizer, Moderna Inc and AstraZeneca Plc.

Who is NOT vaccinated with Pfizer’s Covid Jab and why?

A priority list on which groups should receive the vaccine has been published by the Joint Vaccination and Immunization Committee (JCVI).

The first dose is given to NHS workers, nursing home residents, and those over 80, before slowly moving through the rest of the population depending on their age and underlying health conditions.

However, three groups have been removed from the list:

Pregnant woman

The UK government has issued guidelines that make it clear that expectant mothers should not be vaccinated until after birth.

Women who think they are pregnant are advised to postpone vaccination until they are sure it is not, and those looking to have a baby should also not be vaccinated.

The measure is purely precautionary, however, and it is not uncommon for some groups to be excluded from taking brand new vaccines.

Pfizer’s vaccine was approved by the UK medical watchdog last week with a good safety rating and no evidence that pregnant women are at risk.

However, scientists behind the sting have not tested it on pregnant or breastfeeding women – which is often the case in scientific studies for scientific reasons – so there is no concrete evidence that it is safe or effective.

There are suspicions within the government that one of the more traditional vaccines like that from Oxford University may be safer for pregnant and breastfeeding women.

Children under 16 years

The Pfizer Covid-19 vaccine is also not offered to children under the age of 16.

This is because there is a lack of evidence on how this affects teenagers.

For ethical reasons, no children were recruited in the vaccine trials.

Children are also at low risk for Covid, as the vast majority of those under 16 who get it have mild or no symptoms.

People with severe allergies

The UK Medicines Agency has advised people with a history of serious allergies not to receive the Pfizer vaccine.

The decision was made on Wednesday after two NHS workers suffered a side effect after the injection.

The MHRA has said that anyone with a history of anaphylaxis to a vaccine, drug, or food should not receive the vaccine.

Pfizer had excluded people with a history of significant side effects to vaccines or their ingredients from late-stage studies.

“For the general population, this doesn’t mean they need to worry about vaccination,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

What would be wise, he said, would be “for anyone who has a severe allergic reaction and has to wear an EpiPen to delay vaccination until the cause of the allergic reaction is cleared up”.

Women who think they are pregnant are advised to postpone vaccination until they are sure it is not, and those looking for a baby should also not be vaccinated.

Pfizer’s vaccine was approved by the UK medical watchdog last week with a good safety rating and no evidence that pregnant women are at risk.

However, scientists behind the sting have not tested it on pregnant or breastfeeding women, so there is no concrete evidence that it is safe and effective.

There are around 850,000 pregnancies annually in England and Wales, suggesting that 630,000 women have children at the same time.

Many of them will fall into the lowest priority group for vaccinations anyway because they are pre-menopausal and under 50, with the exception of some geriatric mothers or those with very serious health problems. There is currently no evidence that pregnancy increases the risk of COVID-19.

Children under the age of 16 are also not offered the vaccine due to a lack of data on safety and effectiveness – the sting has only been tested on adults.

“There is currently not enough evidence to recommend vaccinating pregnant women against COVID-19,” said Dr. Mary Ross Davie of the Royal College of Midwives.

However, Public Health England has confirmed that the evidence currently available does not indicate safety concerns or harm to pregnancy.

“There is no evidence of harm, but there is also no up-to-date evidence of safety as, as usual, pregnant women have been excluded from all vaccination attempts.”

While studies have shown that mothers can pass COVID-19 on to their unborn child, there is no evidence that contracting the disease can harm an unborn fetus in any way, as most babies and children with COVID-19 are asymptomatic .

However, scientists need to play it safe with vaccines. If they can’t scientifically prove that something is safe, they won’t.

“We have to complete certain toxicology studies before we can include pregnant women in the studies, and that is all currently being planned,” said Professor Sarah Gilbert, one of the vaccine developers at Oxford, this week.

Dr. Davie added, ‘The RCM is encouraging further research in the near future to evaluate the safety of the vaccine in pregnancy and during breastfeeding.

“While we wait to find out more, we urge all pregnant women to get the free flu shot to protect them from the flu viruses that are circulating this winter.

‘When you receive a dose of [Covid] Before you find out that you are pregnant or unwanted during pregnancy, you should be sure that this will not affect the vaccine’s success and that the risk of harm to your baby is small.

“Public Health England recommends that if you find you are pregnant after a dose of the COVID-19 vaccine, before your second dose is given, you should complete your pregnancy.”

Professor Ian Jones, a virologist at the University of Reading, told MailOnline, “Some, but not all, vaccines are recommended for women during pregnancy.

‘Since there will not have been many pregnant women among the participants in the various Covid Phase III studies, there is no evidence of suitability in one way or another.

“Formally, there should be no reason why vaccines like the BioNTech currently in use could not be given during pregnancy, but pending further data, the Council would follow the precautionary principle and hold back for the time being.

“It is of course worth noting that as the general population is immunized, the likelihood of infection in pregnant women decreases as the virus circulation decreases.”

Pfizer’s Covid Jab is an mRNA vaccine that uses a brand new technology that sends messages to human cells instructing them to produce antibodies.

There are suspicions within the government that one of the more traditional vaccines like that from Oxford University may be safer for pregnant and breastfeeding women.

Oxford’s Sting is a vector viral vaccine that uses a genetically modified, weakened form of the common cold that trains the body to fight Covid-19.

Viral vector vaccines used to immunize people against HPV and meningitis have proven their worth, and scientists have a better idea of ​​their safety profiles.

The Pfizer vaccine guidelines on the Department of Health’s website state: “Due to the new formulation of this particular vaccine, the MHRA would like to see more non-clinical data before completing the pregnancy recommendations.”

Expectant mothers have not been included in clinical trials, and researchers are waiting to see if women got pregnant in trials as a leading indicator. Pictured: The first patient to be enrolled in Pfizer's COVID-19 medical trial at the University of Maryland Medical School in Baltimore receives an injection on May 4th

Expectant mothers have not been included in clinical trials, and researchers are waiting to see if women got pregnant in trials as a leading indicator. Pictured: The first patient to be enrolled in Pfizer’s COVID-19 medical trial at the University of Maryland Medical School in Baltimore receives an injection on May 4th

It is because the UK drug and health product regulator has advised against offering the vaccine to expectant mothers. Pictured: Pfizer headquarters in New York City

It is because the UK drug and health product regulator has advised against offering the vaccine to expectant mothers. Pictured: Pfizer headquarters in New York City

Pregnant women and children would not receive a coronavirus vaccine until next year.

The Joint Committee on Vaccination and Immunization (JCVI) has put together a list of priorities that will determine who should be stung first, based on their risk of dying from Covid.

Nursing home residents and the staff who care for them should be at the front of the queue, followed by NHS staff on the front line andall over 80 years.

But logistically andDue to regulatory issues with the storage and distribution of Pfizer’s shock, hospitals get first access.

The vaccine must be stored at -70 ° C in special freezers not available in most care facilities, and doctors are currently not allowed to split the lots of 975 vials in which they are shipped.

People over 75 are next in line.followed by those over 70, over 65, and high-risk adults under 65 with diseases such as cancer, followed by medium-risk adults under 65 – including diabetics and asthmatics.

They are followed by those over 60, with those over 55 and over 50 forming the final priority groups. Hopefully every vulnerable Briton will be protected by Easter, which has raised hopes of getting back to normal by spring.

The general population will be the last to get their hands on a stab, and the JCVI says they will be prioritized based on age or underlying conditions.

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