Breastfeeding and pregnant women won’t get vaccine
EXPECTANT and breastfeeding mothers will not be able to take the Pfizer coronavirus vaccine, i t has emerged.
The drugs watchdog in the UK, which will be one of the first countries in the world to receive the long-awaited jab, has revealed that expectant and breastfeeding mothers will be excluded from the vaccination programme on safety grounds.
And i t has warned that any woman who does receive it should try not to conceive for at least two months after receiving their second dose.
Maternity care expert Dr Krysia Lynch, told the Irish Daily Mail last night that the warning may force some families to put off having another child.
Pfizer and Moderna, which are developing two high-profile vaccine candidates, have posted initial data from their large late-stage trials that suggests their products could be close to 90% or 95% effective in reducing risk of Covid-19 infection.
But since the vaccine trials have thus far excluded people who are pregnant or breastfeeding, they are not likely to be included in any vaccination drives.
Full authorisation papers for the vaccine, published by the Medicines and Healthcare products Regulatory Agency (MHRA) in the
‘They are still doing the testing’
UK, which is set to roll out the vaccine in the coming weeks, reveals any pregnant or breastfeeding mother will be excluded from the vaccination programme on safety grounds.
The documents also confirm that children under the age of 16 should not be vaccinated.
The advice here is likely to be the same, with the European Medicines Agency set to approve the Pfizer vaccine for use in Ireland by December 29.
This advice may change in the future – and it is not clear whether the Oxford vaccination programme will be able to include some of the excluded groups when it receives authorisation.
Britain’s Medicines and Healthcare Products Regulatory Agency document said: ‘It is unknown whether Covid-19 mRNA Vaccine BNT162b2 is excreted in human milk. A risk to the newborns/ infants cannot be excluded.
‘Covid -19 mRNA Vaccine BNT162b2 should not be used during breast-feeding.’
It added: ‘For women of childbearing age, pregnancy should be excluded before vaccination. Women of childbearing age should be advised to avoid pregnancy for at least two months after their second dose.’
A spokesperson for the Irish Health Products Regulatory Authority (HPRA) said: ‘Due to ethical issues, it is generally accepted that pregnant women are not included in clinical trials of new medicines or vaccines.
‘However, studies are ongoing within the EU so that we can better learn about the impact of Covid- 19 illness in pregnancy, which will better inform advice around the benefits of vaccination.
‘At the time of approval, the EMA and the HPRA will provide information available on use in pregnancy, as well as any special warnings or restrictions for use.‘
A spokesman for the Department of Health last night said: ‘Ireland is currently involved in an EU procurement exercise being operated by the European Commission on behalf of member states to procure suitable, safe and effective vaccines, in sufficient quantities, to combat Covid-19.
‘Covid-19 vaccines can only be approved and used if they comply with all the requirements of quality, safety and efficacy set out in the EU pharmaceutical legislation. No vaccine will be used until market authorisation from the European Medicines Agency is obtained and any authorised vaccine will be subject to ongoing monitoring by the HPRA.’
The Pfizer team excluded pregnant women in its trials – as is standard practice for new vaccines and drugs. Some women, however, will have become pregnant during the trial, and they will be carefully monitored.
Leading immunologist Professor Luke O’Neill told the Mail that people should not doubt the safety of the vaccine on the basis that pregnant women cannot receive the jab.
He noted that since children in the 1950s and 1960s were born with birth defects due to the Thalidomide scandal, the drug industry has been extremely cautious about trialling new medicines in pregnant women.
Prof O’Neill said: ‘It is standard practice with a brand-new vaccine. First of all, they do trials in the majority. You want to get a wide range of ages and ethnicities.
‘With any new medicine or any new vaccine, there’s a risk of causing problems with the developing baby and they are really careful about this. Until they get those results, they proceed cautiously.
‘Most vaccines are fine for pregnant women. But, because it’s so new, they’re still doing the testing. It will happen in time; I wouldn’t have any concerns and it will, eventually, be rolled out to pregnant women.’