Covid Scotland: Vaccines ruled out in neonatal deaths spike

Public Health Scotland (PHS) said its consultants had given “careful consideration” to the “potential benefits and harms” of carrying out such as analysis as part of its probe into the tragic deaths of 39 infants, but concluded against doing so because “it was not possible to identify a scenario that would have resulted in a change to public health policy or practice” given that vaccination policy was already “appropriately informed by good-quality population-level evidence and safety data”. 

Scotland neonatal death rate exceeded the upper control limit (red dotted line) for the first time in September 2021, then again in March 2022. Since May this year levels have been below average (Source: Public Health Scotland) (Image: PHS)

In a statement, PHS added that there was also a risk that “identifying the vaccination status of the mothers, even at aggregate level, would result in harm to those individuals and others close to them, through actual or perceived judgement of the effects of their personal vaccination decision”. 

Furthermore “the outcomes of such analysis, whilst being uninformative for public health decision making, had the potential to be used to harm vaccine confidence at this critical time”. 

The decision came to light after the Herald on Sunday obtained internal emails and reports under freedom of information tracking the PHS response, with one email dated November 24 2021 stating: “We do not have any plans to examine maternal vaccination status, as there is no public health reason to do so”. 

Previously PHS had said would not be disclosing the information to protect patient confidentiality.

READ MORE: Antivaxxers are blaming Covid vaccines for neonatal deaths - a lack of transparency won't help

It comes days after the Scottish Government announced that Healthcare Improvement Scotland would carry out a review into all reported neonatal deaths between April 2021 and the end of March this year in order to identify "anything that may have contributed" to the spikes.

A year on, the cause remains a mystery, with preliminary investigations by PHS finding "no direct link" with Covid infections in either the mothers or infants and "no clear increase in occurrence of prematurity", according to an internal report from June this year.

Chance variation is considered unlikely "given the magnitude and consistency" of the changes, but the report does point to "social and economic pressures of the pandemic period" as a plausible explanation as well as problems around healthcare, adding that the neonatal network "has reported periods of staffing pressure, in part due to Covid-19 staff absences".

Nursing and midwifery vacancy rates in Lothian have climbed sharply since late 2020 and are the highest in Scotland (Source: Turas Workforce database) (Image: PHS)

Investigators examining regional variation in relation to the September 2021 spike - when 21 newborns died - found that the neonatal mortality in NHS Lothian had been nearly twice the national average - at 8.9 per 1000 live births compared to 4.9 per 1000 for Scotland as a whole. 

NHS Lothian has seen its vacancy rate for nurses and midwives treble from 4.1% in September 2020 to 12.5% by June this year - the highest rate for any health board. 

However, the PHS report dated October 2021 cautions that small numbers mean “it is possible that differences by area simply represent chance variation”. 

Alarm bells first sounded late last year when data showed that Scotland’s neonatal mortality rate had spiked to 4.9 per 1,000 live births in September.

This was the highest level since monthly monitoring began in July 2017, and the first time that an upper warning threshold - known as the control limit - had been breached. 

The rate was more than double the expected level of 2.2 per 1000 live births, based on the pre-pandemic average from July 2017 to December 2019.

This would have corresponded to nine deaths, instead of the 21 which occurred. 

READ MORE: Investigation launched amid second 'unusual' spike in neonatal deaths

The abnormal surge triggered an automatic investigation but just six months later public health teams were stunned by a second out-of-the-ordinary spike when 18 neonatal deaths were reported in March, more than double the expected eight. 

Uptake of first, second and booster vaccine doses in pregnant women has been slower than the general population, but peaked in June, August, and late December respectively (Source: PHS) (Image: PHS)

Spikes in Covid infections among pregnant women were consistent with trends in the general population, with surges in August/September and then January and March as Omicron spread (Source: PHS) (Image: PHS)

In email correspondence from April, one PHS consultant writes that it is “concerning to have another month with strikingly high figures so soon after last September”. 

Scotland is unusual, both within the UK and internationally, because it tracks neonatal mortality on a monthly basis.

Results from May to August this year show below-average neonatal mortality.

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The most recently available data for England and Wales covers 2020. As a result, if similar spikes have occurred they are unlikely to have been detected yet. 

The findings also propelled Scotland into a global spotlight as antivaxxers as far afield as Argentina and New Zealand shared the reports online to falsely claim it as proof that Covid vaccines were killing infants.

In fact, a wealth of surveillance data globally illustrates that the vaccines deliver an overall benefit. 

According to cumulative data from December 2020 up to the end of July 2022 - covering tens of thousands of pregnancies in Scotland - the perinatal mortality rate (neonatal deaths and stillbirths combined) was 4.5 per 1000 births for babies born to mothers vaccinated at any point in pregnancy, and 6.1 per 1000 where mothers had been vaccinated in the final 28 days before delivery. 

Graphic published by Scotland's COPS study in January 2022. At that point, rates of perinatal mortality were highest (22.6/1000) in babies born within 28 days of their mothers testing positive for Covid. This compared to a background rate of 5.6/1000 for March 2020 to October 2021, and 4.3/1000 for babies born to vaccinated mothers (Source: COPS) (Image: PHS)

Meanwhile, a Covid infection during pregnancy - especially in the final month before delivery - is associated with an elevated rate of perinatal mortality, with unvaccinated expectant mothers significantly more likely to be hospitalised with Covid. 

Data up to the end of April 2022 shows that the perinatal mortality rate for babies born to mothers who tested positive for Covid at any time during pregnancy was five per 1000 births, rising to 13.1 per 1000 where the infection occurred in the final 28 days before birth. 

From March 2020 to October 2021, overall perinatal mortality in Scotland was 5.6 per 1000 births.

This covers all births, including to mothers who were neither vaccinated nor tested positive for Covid at any point.  

Unvaccinated mothers account for the vast majority of Covid hospitalisations. While vaccination cannot necessarily stop infection, it provides strong protection against severe disease (Source: COPS) (Image: PHS)

Sarah Stock, a professor in maternal and foetal health at Edinburgh University who has led the Covid-19 in Pregnancy in Scotland (COPS) study, said it made sense to rule out any link with Covid vaccines based on existing evidence. 

Prof Stock said: “If you think about how you’re going to do an investigation, you want to look for anything that could be plausibly linked to the sad increase in baby deaths that we saw.

"You can’t go looking for things that we know are not associated. 

“The global evidence is now very conclusive that vaccination is safe in pregnancy, and before pregnancy, and there is no association with baby deaths.

“There’s no plausible reason why you’d look at it in this small number of cases.

“The right way to look at whether something causes something is to do it in big numbers, population data - that’s what we’ve done and that shows us that Covid-19 does cause problems in pregnancy, and vaccination does not.

"Covid-19 vaccination is the safest way to prevent complications in mothers and babies.”

Uptake of the vaccine had been considerably slower in pregnant women, but began to become "more similar" to the general population from September 2021. 

Nonetheless, just 78% of women who gave birth in July this year had had at least one vaccine dose compared to 88% overall for women aged 18 to 44. 

The review by Healthcare Improvement Scotland is expected to take no longer than six to nine months (Image: PA)

Prof Stock said that even if none, or few, of the mothers bereaved in the September and March spikes had received the Covid vaccine she would be uncomfortable with putting such personal information into the public domain, even on the grounds of trying to counter misinformation. 

She added: “We have to think carefully about the rationale for doing it. 

“And the flipside for me is that we know Covid-19 infection in pregnancy can cause complications - that’s plausible, they’ve looked at that in this investigation. 

“Now, they’ve said there’s no clear direct link - but that doesn’t give me any reassurance that Covid-19 doesn’t cause problems in pregnancy. It just makes me think that in this small number of cases it didn’t play a part. 

“So that’s not the right way to look at it this.”

READ MORE: Scotland's downward spiral in life expectancy isn't inevitable - just look at Ireland 

However, Prof Stock added that it was “entirely plausible” that short-staffing and pandemic pressures had played a part.

“We know that for safe care, we need adequate staffing,” she said. 

Jaki Lambert, director for Scotland at the Royal College of Midwives, said it welcomes the HIS review and “any learning that can be shared must be done in a timely manner”. 

She added: “Having the right number of staff, in the right place with the right skill mix is crucial to delivering safe high-quality maternity care and the evidence clearly shows us that this improves outcomes for women and their families.”