Why is the MHRA hiding critical safety data on the covid vaccines?

They are still withholding the crucial pregnancy outcomes data

We have reported before on the basic failings of the MHRA in their duty with respect to safety monitoring of the covid vaccines. Now, we can reveal a new scandal as a result of a Freedom of Information Request by the tenacious Cheryl Grainger about the 2000 pregnant women who were vaccinated in the first half of 2021 who the MHRA were supposed to have been monitoring.

Summary

• Following Cheryl’s FOI of 13 April 2023 asking for the outcome data on the monitored pregnant women, on 19th July 2023 the MHRA stated that they had all of the information Cheryl requested but refused to release it, citing exemption under Section 22 of the FOI Act; this exemption applies when a ‘future’ report is to be issued containing the relevant information.

• Even though all the relevant pregnancy outcomes data would have been known by mid 2022, the MHRA provided no information as to when this ‘future’ report would be issued.

• The MHRA did, however, send Cheryl a copy of a redacted report dated July 2021 marked “Not for Publication” sent to the Pharmacovigilance Expert Advisory Group (PEAG) for advice.

• This report to the PEAG provided information about the adverse drug reactions (ADRs) reported up until 30 June 2021 by the Yellow Card Vaccine Monitor (YCVM) Group (a self selected group of 30,000 people who registered to provide regular updates of any adverse reactions to their vaccinations).

• An astonishing 53% of all those in the YCVM reported at least one ADR (adverse drug reaction). Of those receiving the AZ vaccine 59.2% reported at least one ADR, compared to 38.8% for Pfizer and 59.3% for Moderna.

• There were 1366 pregnant women in the YCVM. Of those who received the AZ vaccine a whopping 66% (124 out of 203) reported at least one ADR; 38% of the Pfizer recipients and 61% of the Moderna recipients reported at least one ADR.

• Because of the timing of the report to the PEAG there is only minimal information on the pregnancy outcomes (only 6 births in total had been recorded by 30 June 2021).

• Despite the report making clear the high importance of continuing the YCVM the scheme appears to have been halted shortly after the July 2021 report. This suggests that the promised report being withheld now under Section 22 of the FOI Act must have been completed well over a year ago.

• Despite the obvious safety signals in the ‘not for publication’ report sent to the PEAG in July 2021 we do not know what the PEAG response was. It is possible that the quiet (still not officially announced) withdrawal of the AZ vaccine around this time was one result of the report, but it begs the question why the entire vaccine programme was not halted at this point.

Cheryl Grainger's FOI to June Raine of the MHRA, 13 April 2023

Dear Dame June Raine

FREEDOM OF INFORMATION REQUEST

On 17^th November 2022 you gave a recorded lecture at the All-Wales Therapeutics and Toxicology Centre at the AWMSG 20th Anniversary Conference - The Nicola Wheatley Memorial Lecture.

During that lecture you spoke of the Yellow Card Monitor as an active surveillance of specifically identified cohorts and specifically mentioned a group of 2000 pregnant women who shared their data via the monitor. You were very pleased that this specific group gives you a denominator to presumably work out more accurate data analysis.

FOI Questions on active surveillance of 2000 pregnant women:

1. How were the pregnant women monitored, how often did they report and how long were they followed for?

2. When were they vaccinated, in which trimester, and how often were they vaccinated and with which vaccine?

3. What was the % of the 2000 pregnancies experiencing:

   1. miscarriage?

   2. still births?

   3. spontaneous abortions?

4. What was the % of the 2000 pregnancies that delivered:

   1. to full-term?

   2. pre-term?

5. Was there any congenital malformation?

6. What were the serious adverse side effects for:

   1. Mother?

   2. Baby?

7. What were the less serious adverse side effects for:

   1. Mother?

   2. Baby?

8. Were there any women followed up whilst breast feeding?

   1. Were any AEs recorded?

   2. Any breast milk discolouration, paresis, suppressed lactation, pain?

9. Did this cohort of 2000 pregnant women influence the MHRA risk/benefit analysis in pregnancy?

I believe that I should receive a response within the 20 day period from receipt.

Yours sincerely

Cheryl Grainger BSc

The MHRA reponse, 19 July 2023

We confirm that we hold the information you have requested. However, we consider the information to be exempt under Section 22 (Information held with a view to its future publication) as we are working on a scientific publication in relation to the information you have requested.

Section 22 is a qualified exemption and as a result we have considered the public interest in applying this exemption. We acknowledge that there is significant interest in the safety of medicines in those who are pregnant, including vaccines for COVID-19. However, we do have publicly available information on our position on the use of COVID-19 vaccines in those who are pregnant. This position is based on analysis of all Yellow Card data and relevant data from other sources rather than the subset of data which relates to Yellow Card Vaccine Monitor, to which your request relates. Given this we do not consider that the public interest is best served by releasing the information to you ahead of its formal publication.

Our position on the safety of COVID-19 vaccines in pregnancy can be found on our website via the link below (please follow the link and scroll down to the section entitled ‘Comments on safety in specific populations’):

https://www.gov.uk/government/publications/coronavirus-covid-19-vaccine-adverse-reactions/coronavirus-vaccine-summary-of-yellow-card-reporting

It may be helpful to explain the process for assessment of data arising from the Yellow Card Vaccine Monitor programme. Data arising from this element of the Covid-19 vaccine surveillance strategy is continuously assessed alongside other data we collect or have access to, to support our signal detection activities, as such there are not regular reviews of this data source in isolation. The MHRA is developing a scientific publication of Yellow Card Vaccine Monitor, which will discuss the totality of the data collected including the specific points you have requested above. However, in order to provide some information in the interim we have attached an interim review of the Yellow Card Vaccine Monitor data that was presented to our Pharmacovigilance Expert Advisory Group in July 2021. You will note that at this stage 1197 individuals had reported that they were pregnant. Final numbers of registrations as well as analysis of outcomes will be included in our scientific publication in due course. Please note that there is some information redacted in this document. We have applied these redactions under Section 40 (2) of the Freedom of Information Act. The redacted information is personal data (names of members of staff), and its disclosure would lead to the identification of individuals. The staff names withheld are those of members of staff below a certain level of seniority; this is consistent with our approach to the disclosure of staff names.

If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Yours sincerely

MHRA Customer Experience Centre

Communications and engagement team

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

The ‘not for publication’ redacted report for the PEAG

Here is the 13-page report:

Peag Yellow Card Vaccine Monitor Final

439KB ∙ PDF file

Download

Download

Key points and conclusions to note in the report for the PEAG

• This particular report is the same one that Nick Hunt was sent earlier this year - see his article.

• 600,000 people were ‘invited’ to register for the YCVM scheme with the aim of contacting registered vaccinees at set intervals (“for example 7 days, 14 days, 3-6 months”). Of these 29,832 vaccinated subsequently registered but only 24,611 responded. Of those for who the vaccine make taken was known 67% were AZ, 32% Pfizer and 1% Moderna. The YCVM Group was disproportionately elderly, with 61% being over 60 years old.

• This report also provides some basic information about ADRs reported up until 30 June 2021 the Yellow Card Scheme (i.e. all other reports of ADRS submitted to the notoriously complex to complete MHRA Yellow card scheme.

• In the YCVM Group 53% reported at least one ADR by 30 June 2021. Of those receiving the AZ vaccine 59.2% reported at least one ADR, compared to 38.8% for Pfizer and 59.3% for Moderna. A major safety signal all round but especially for AZ.

• In the Yellow Card scheme there were 303,203 individuals reporting ADRs by 30 June 2021. Despite the fact that it was the over 60s who had been primary vaccinated by then an astonishing 78% of those reporting ADRs were under 60. This contrasts with 47% in the Monitor group (which was disproportionately elderly). Another major safety signal. Curiously, unlike for the YCVM, there is no breakdown on ADRs reported for the different vaccine makes.

• In both the YCVM group (65%) and the Yellow Card Scheme (75%) far more women than men reported ADRs.

• While the report notes 82 million doses of the vaccine had been delivered by end of June 2021 (perhaps implying that the 303,203 individuals reporting ADRs was therefore not excessive) it fails to draw the obvious conclusions about under-reporting of the notoriously difficult to use Yellow Card scheme. Since 53% of those in the YCVM group reported ADRs there is no reason to believe that a significantly different proportion of individuals would have reported ADRs if they had been actively monitored. Assuming about 30 million people had been vaccinated by 30 June 2023 this means we might have expected 15 million to have had an ADR rather than the 303,203 who did report. The 303,203 who did report represent only about 1% of that 30 million vaccinated people, rather than the 53% rate (~15 million) implied by the YVCM data.

• The main report and appendix provide inconsistent numbers about vaccinated pregnant women in the YCVM Group, but as the appendix provides greater details we use the data there. We note there that there were 1366 reports of maternal exposures during pregnancy up to 30th June 2021, including data from 187 recipients of the Oxford-AZ vaccine, 1003 recipients of the Pfizer-BioNTech and 95 recipients of the Moderna vaccine. Of these, 565 participants reported ADRs following vaccination up to 9th July 2021. Thus, 66% (n= 124) of recipients of the Oxford-AZ vaccine, 38% (n=383) of recipients of the Pfizer-BioNTech and 61% (n=58) of recipients of the Moderna vaccine reported ADRs and were included in the analysis. The fact that, when this report was completed most of the women were still pregnant (a total of only 8 live births among the 565 reporting ADRs had been recorded by 9 July 2021) makes the need to answer the questions asked by Cheryl Grainger so imperative.

• Point 26 in the report states “Given the volume of pregnant women enrolled in the YCVM, we have an important future data source to support continuous and long term monitoring of pregnancy outcomes and will provide an update to the VBR in due course.” Yet the MHRA is still refusing to publish the results of these outcomes two years later.

• While the report stresses the high importance of continuing and improving the Monitoring Scheme, Nick Hunt believes the Target Active Monitoring (YCVM) was quietly dropped in Mid-2021. He comes to two conclusions: either the MHRA is not doing the Covid vaccine surveillance as promised; or it is doing it and not making the results publicly available. Certainly, the promised update report with the pregnancy outcome data being withheld now under Section 22 of the FOI Act must have been completed well over a year ago. Buttressing this conclusion is the fact that, in her lecture on 17 Nov 2022, MHRA CEO June Raine made a statement about the YCVM in pregnancy.

Here is a live interview I did about this on UK Column News, 7 August 2023

PS: The MHRA have still not responded to my FOI about their bizarre approval process for the SKYCovian vaccine.

..and this: