In NZ the #covidvaccine technical advisory group is called CV-TAG. It is their job to "independently" assess international safety and efficacy data and inform our Govt on safety implications #covidvaccine. They were tasked with this re the roll out of the vax for 12 to 15 years.
In Aug 21 with awareness of the clear safety signal of myocarditis especially in young males, they recommended only health compromised high risk receive it. 3 days before cabinet meeting CV TAG overrode their own advice, moving to full roll out to age 12 - 15.
Coneyed by 1 2 line memo Its lack of detail suggests that this was the result of a hasty political decision that was being rubber-stamped by the advisory group.
At the same time in UK the CVTAG equivallent said "The margin of benefit, based primarily on a health perspective, is considered too small to support advice on a universal programme of vaccination of otherwise healthy 12 to 15-year-old children at this time."
"As longer-term data on potential adverse reactions accrue, greater certainty may allow for a reconsideration of the benefits and harms. Such data may not be available for several months.”
On Sept 21 2021 CVTAG again expressed concern suggesting they should revisit their own decision re safety for all 12 - 15 yrs. In July 2021 they advised our govt that an increased gap between doses reduced #myocarditis risk.
Their ensued ongoing discussion and tension between CV-TAG and Govt who felt an extended gap would HAMPER THE ROLL OUT irrespective of safety issues. On Aug 12 the Govt did decide to increase the gap between doses from 3 to 6 weeks.
At the CV-TAG meeting on 17 Aug it was noted that A REQUEST HAD BEEN MADE TO REMOVE THE PUBLIC COMMUNICATIONS AROUND AN EXTENDED GAP BETWEEN DOSES REDUCING RISK OF MYOCARDITIS. It is not clear who made the request.
It appears that a communications strategy took precedent over providing accurate medical advice to the public which was a necessary element of informed consent.
The request also suggests that there was a reluctance within government to fully articulate the myocarditis risk to young people, provide them with advice, for instance, on resting after vaccination as was given in Singapore
On 6 October another seemingly inexplicable decision was announced. The government reversed its position on dose intervals by announcing that it was going back to a three week recommendation for everyone eligible for vaccination
This was completely at odds with the CV TAG memo sent to MOH in July alerting to increased safety with an extended gap between doses.
Politically Govt bounced about It began by following Pfizer’s recommended dosing schedule of a three week interval. Then ignored CV TAG’s recommendation of at least eight weeks for the under 30s that was made in mid-July,
instead recommending a six week interval to the public in mid-August before finally reverting back to a three week interval in early October.
NZ policy reversal significant implications for under 30s inc mandated that required them to be vaccinated with two doses not more than six weeks apart despite a CV TAG recommendation that they be permitted at least an eight week interval due to their increased risk of Myocard
Affected children 12 to 15 who had only been approved for vaccination at a time when the recommended dose interval had been extended to six weeks and who were also within the age group that was at an increased risk of myocarditis from the shorter dose interval.
#Israel was one of the 1st countries to roll out #pfizer#covidvaccine nationwide. They only used Pfizer and heavily vaccinated the population. For the first year of roll out they had virtually NO safety pharmacovigilence system in place to find early safety warnings and respond
Finally in early 2022 a team was convened to collect and analyse #adverseevent data. The team identified 22 categories of adverse events, including safety signals not listed by Pfizer such as neurological side effects, tinnitus and others.
They also found that there were many long-term adverse reactions; in 50% of the reports in which duration was mentioned at all, the side effect lasted longer than SIX MONTHS.
In #nz the #covidvaccine Advisory Group CV-TAG strongly advised our Govt NOT to mandate 2 doses to children aged 18 and below due to unfavourable risk/benefit profile
They said: 11/11/21 younger age groups are more at risk than older age groups of myocard after dose the second dose of Pfizer vaccine, while a robust antibody response and early limited clinical effectiveness data indicate some protection from Vax after 1 dose of Pfizer
"consideration should be given to permitting younger people who have had one dose to be permitted to work or undertake other activities covered by the mandate"
In Dec 2021 the NZ Tech Advisory Group tasked with advising our Govt re safe use of the #covidvaccine strongly recommended that your child was at very low risk of harm from covid but very real risk of HEART DAMAGE from 2 doses of #mrna
They advised the Govt (twice) that your under 18 year old should NOT be mandated to receive 2 doses of #pfizer because of this unfavourable risk/benefit profile
Here, we posit that the reporting period for AEs related to the COVID-19 vaccines may need to be longer (than the traditional 6 weeks for other vaccines)
In this retrospective, observational study, we aimed to assess the chronology of new/worsening ailments occurring after the administration of COVID-19 vaccines based on the changes to the participants’ pharmacological records.
Patients vaccinated against COVID-19 and experiencing health-related events during the study period (between September 30, 2021 and July 15, 2022) were included and the changes to their pharmacological records were analyzed.