The Royal College of Midwives has called for pregnant women to be supported after it was recommended yesterday under-30s should be offered an alternative to the Oxford/AstraZeneca jab.
Under-30s who are in phase 1 of the vaccine rollout, and remain unvaccinated, should be offered an alternative Covid vaccine to the Oxford one if it is available, the Joint Committee on Vaccination and Immunisation (JCVI) has said.
The Medicines and Healthcare Products Regulator Agency (MHRA) is still reviewing whether the AZ vaccine should be offered to under-30s when phase 2 of the vaccination rollout – which includes healthy adults aged under 49 – begins, Nursing in Practice‘s sister title Pulse wrote yesterday.
The Royal College of Midwives trade union has pointed out pregnant women, who are extremely clinically vulnerable, under 30 have had their ‘options severly limited’.
‘Pregnant women should not be excluded from the vaccination programme and we urge the MHRA and JCVI to redouble their efforts to support this group,’ Birte Harlev-Lam, executive director midwife at the RCM, stated.
The JCVI said yesterday second doses should continue to be given to all patients who had the AZ jab for their first dose, which should include pregnant women. The union urged pregnant women to speak to their midwife or obstetrician with questions or concerns they may have.
The recommendation follows MHRA’s review into reports of blood clots following vaccination, which had been thought to affect young women in particular.
The MHRA has concluded that more work is needed to review the matter but that based on the current evidence, the benefits of the AZ Covid vaccine continue to outweigh the risks for the ‘vast majority’ of people.
The MHRA has had 79 case reports of thrombosis following the first vaccine dose of the AZ vaccine – 19 people ‘have sadly died’, the MHRA said. Three out of the 19 were under 30.
The JCVI said ‘there is currently a high level of uncertainty in estimates of the incidence of this extremely rare adverse event by age group’ but that ‘the available data do suggest there may be a trend for increasing incidence of this adverse event with decreasing age, with a slightly higher incidence reported in the younger adult age groups’.
However this comes as the European Medicines Agency (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC) said today that it found that no particular age group was more at risk of blood clots than any other.
The new EMA recommendation is that rare blood clots should be listed as possible side effects of the vaccine, following its own review of the link. But it said that ‘overall’ the benefits of having the vaccine still ‘outweighs the risks’.
The new JCVI statement said: ‘There are some adults <30 without underlying health conditions who are in phase 1, who were prioritised due to an increased risk of exposure and/or to reduce the risk of passing the infection on to vulnerable individuals. This includes health and social care workers, unpaid carers and household contacts of immunosuppressed individuals. Acting on a precautionary basis, if these persons are still unvaccinated, it is preferable for them to be offered an alternative Covid-19 vaccine, if available.
‘JCVI is currently finalising its advice on phase 2 of the programme, particularly for healthy people under 30 years of age, and this will be published in due course.’
But it said that ‘to date’ there were ‘no reports of the extremely rare thrombosis/thrombocytopenia events following receipt of the second dose’ of the AZ vaccine.
Therefore ‘all those who have received a first dose of the AstraZeneca Covid-19 vaccine should continue to be offered a second dose of AstraZeneca COVID-19 vaccine, irrespective of age’.
Meanwhile, the MHRA has announced new advice to healthcare professionals to take into account before administering the AZ vaccine to patients, including weighing up their risk of blood clots. It has also issued to advice on symptoms to look out for following vaccination.
Professor Wei Shen Lim, Covid-19 chair for JCVI said: ‘We are advising a preference for one vaccine over another vaccine for a particular age group – really out of the utmost caution rather than because we have any serious safety concerns.’
News that the UK medicines regulator was considering restrictions on the use of the Oxford/AstraZeneca Covid vaccine in patients under 30 broke earlier this week. But it comes as an EMA safety review last month had concluded that the vaccine ‘likely reduces’ the risk of blood clots overall.
The EMA today said in a briefing that ‘a plausible explanation for these rare side events is an immune response to the vaccine – leading to a condition similar to one seen sometime in patients treated with heparin induced thrombocytopenia’.
A number of European countries have previously suspended the use of the AstraZeneca vaccine in younger age groups.
The MHRA has continued to urge patients to continue to turn up for their AstraZeneca Covid vaccination but GPs told Nursing in Practice‘s sister title Pulse that many patients had already been put off by the news of the European suspensions and were turning down the jab or not turning up at all.
Meanwhile, AstraZeneca’s phase-3 trial for the US market concluded that the vaccine presents ‘no increased risk’ of blood clots.
The University of Oxford yesterday said it has paused its trial of the vaccine in children while awaiting the results of the review.
A university spokesperson said: ‘Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial.
‘Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions.’
It was reported last month that children could be vaccinated against Covid-19 as soon as August, pending the results of the trials.
What has the MHRA found so far?
Up to and including 31 March 2021, the MHRA had received 79 UK reports of blood clotting cases alongside low levels of platelets following the use of the Covid-19 Vaccine AstraZeneca:
44 of the 79 cases were of CVST with thrombocytopenia
35 of the 79 cases were of thrombosis in other major veins with thrombocytopenia
79 cases occurred in 51 women and 28 men, aged from 18 to 79 years. It should be noted that more women have been vaccinated with COVID-19 Vaccine AstraZeneca than men.
Sadly, 19 people have died out of the 79 cases – 13 females and 6 males. 11 out of the 19 people who died were under the age of 50, 3 of whom were under 30. 14 of these 19 cases were of CVST with thrombocytopenia and 5 were of thrombosis with thrombocytopenia.
All 79 cases occurred after a first dose of the vaccine.
Up to and including 31 March the MHRA received two reports of blood clots (thromboembolism) reported with thrombocytopenia for the Pfizer/BioNTech vaccine. By this date, approximately 11 million first doses and 3.5 million second doses had been given.
Additional reporting by Awil Mohamoud