Pregnant women in the US will probably be denied coronavirus vaccines until next year

pregnant women in the us will probably be denied coronavirus vaccines until next year

Sumary of Pregnant women in the US will probably be denied coronavirus vaccines until next year:

  • Pregnant women in the US will likely have to wait to receive Pfizer Inc’s coronavirus vaccine after it is approved by the Food and Drug Administration (FDA)..
  • Data from the Centers for Disease Control and Prevention (CDC) show pregnant COVID-19 patients are twice as likely to be admitted to ICUs and three times more likely to need mechanical ventilation than non-pregnant women with the disease..
  • However, no vaccine trials to date have included pregnant women – and they are not expected to until after the first quarter of 2021 – meaning there is no safety data..
  • Researchers want to determine the vaccines are safe and effective in healthy, non-pregnant people before testing them in mothers-to-be and their future children..
  • The trial scientists also want to see if any female participants became pregnant during the vaccine studies as an early indicator of how the shot behaves..
  • It comes after the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidelines making it clear pregnant women should not be inoculated until after they have given birth..
  • The FDA will likely not include pregnant women in groups that can receive the Pfizer coronavirus vaccine once it is approved (file image) For example, expecting mothers have never been included in flu shot studies, but have been encouraged by doctors to get it after years of data showing the jab behaved normally in healthy participants..
  • However, doctors say they are concerned because millions of pregnant or breastfeeding women make up the workforce..
  • In fact, according to the CDC, 75 percent of the health-care workforce are female and about 330,000 healthcare workers ‘could be pregnant or recently postpartum at time of vaccine implementation.’ Recently, the Society for Maternal-Fetal Medicine called on the federal government to include pregnant and lactating women in vaccine trials..
  • And, in an op-ed in STAT News, three professors from Johns Hopkins urged the FDA to allow pregnant or postpartum healthcare workers to be allowed to receive the shot..
  • ‘We disagree with the position of the UK authorities that may make it impossible for pregnant or lactating health workers to get the vaccine regardless of their circumstances,’ they wrote..
  • ‘If we are unable to offer vaccines to pregnant or lactating frontline health workers, it is incumbent upon health care systems to offer them alternative protection strategies such as shielding, reassignment, or paid leave..
  • ‘Yet this may not be a viable strategy for most health care facilities, which cannot afford to operate without a significant portion of their workforce.’ However, the UK government has urged pregnant women not to receive any vaccine that have been or could be approved, including those made by Pfizer, Moderna Inc and AstraZeneca Plc..
  • Women who think they might be pregnant are urged to delay vaccination until they are certain they are not, and those trying for a baby should not be immunized either..
  • Pfizer’s vaccine sailed through approval from Britain’s medical watchdog last week with a good safety rating and no evidence to suggest pregnant women are at risk..
  • But scientists behind the jab haven’t tested it on pregnant or breastfeeding women so there is no concrete evidence showing it would be safe and effective..
  • The first batch of doses will be given to NHS workers, care home residents and the over-80s, before slowly making its way through the rest of the population based on age and underlying health conditions..
  • Women who think they might be pregnant are urged to delay vaccination until they are certain they are not, and those trying for a baby should not be immunised either..
  • But scientists behind the jab haven’t tested it on pregnant or breastfeeding women – often the case in scientific trials for ethical reasons – so there is no concrete evidence showing it would be safe and effective..
  • There is suspicion within Government that one of the more traditional vaccines, such as Oxford University’s, may be safer for pregnant and breastfeeding women..
  • Children are also deemed low risk from Covid, because the vast majority of under-16s who catch it suffer only mild symptoms or none at all..
  • Britain’s medicines regulator has advised people with a history of significant allergies not to get the Pfizer vaccine..
  • The MHRA has said anyone with a history of anaphylaxis to a vaccine, medicine or food should not get the vaccine..
  • Pfizer had excluded people with a history of significant adverse reaction to vaccines or its vaccine’s ingredients from late-stage trials..
  • What would be wise, he said, would be ‘for anyone who has known severe allergic reaction such that they need to carry an EpiPen to delay having a vaccination until the reason for the allergic reaction has been clarified.’ There are around 850,000 pregnancies per year in England and Wales, suggesting 630,000 women are carrying a child at any one time..
  • Many of them will fall in the lowest priority group for vaccination anyway, being pre-menopausal and with under-50s last in line, except for some geriatric mothers or those with very serious health conditions..
  • ‘Currently there is not enough evidence to recommend vaccinating pregnant women against COVID-19,’ said Dr Mary Ross Davie from the Royal College of Midwives..
  • ‘However, Public Health England has confirmed that the current evidence available does not indicate any safety concern or harm to pregnancy..
  • ‘There is no evidence of harm, but there is also no current evidence of safety as pregnant women were, as is normal, excluded from all of the vaccination trials.’ While studies have suggested mothers can pass COVID-19 onto their unborn child, there is no indication that contracting the illness can harm an unborn fetus in any way, as most babies and children with COVID-19 are symptom-less..
  • ‘We have to complete particular toxicology studies before we can enroll pregnant women in the trials, and that is all in the planning stages at the moment,’ Professor Sarah Gilbert, one of the Oxford vaccine developers, explained this week..
  • ‘While we wait to learn more about this, we are urging all pregnant women to avail of the free flu vaccination, so they are protected against flu viruses circulating this winter..
  • ‘If you receive a dose of the [Covid] vaccine before finding out you are pregnant, or unintentionally while you are pregnant, you should be reassured that it will not affect the vaccine’s success and the risk of harm to your baby is low..
  • ‘Public Health England recommends that if you find out you are pregnant after you’ve had one dose of the COVID-19 vaccine, you should complete your pregnancy before you have your second dose.’ Professor Ian Jones, a virologist at the University of Reading, told MailOnline:.
  • ‘As there will not have been many pregnant women among the participants of the various Covid phase III trials there is no evidence one way or another regarding suitability..
  • ‘It worth remembering of course that as the general population becomes immunised there will less and less chance of pregnant women becoming infected as virus circulation will fall.’ Pfizer’s Covid jab is an mRNA vaccine that uses brand-new technology which sends messages to human cells instructing them to produce antibodies..
  • Oxford’s jab is a viral vector vaccine which uses a genetically modified weakened form of the common cold which trains the body to be able to fight Covid-19..
  • ‘Because of the new formulation of this particular vaccine the MHRA wants to see more non-clinical data before finalizing the advice in pregnancy.’ Pregnant women and children would not be in line to receive a coronavirus vaccine until well into next year…

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