Situation Update on Covid-19 Vaccine Adverse Effects By Brian Simpson
It is the tale not of two cites, a la Charles Dickens, but of two countries, when comparing the relatively low incidences of adverse effects from the Covid-19 vaccines in Australia, to the much more substantial US statistics. Material about this is reproduced below, in a one-stop information shop. But, it is only early days yet for Australia compared to the US, and we must keep our eyes on the ball, sorry, syringe. Think of it like this. The probability of winning a lottery is small, you most likely will not. Yet, you cannot conclude from that fact alone that no-one will win, as someone always does (assume a fixed number draw rather than X-lotto). Now imagine a bad lottery, where the winner gets …blood clots! If the probability of blood clots is 1 in 109,500, that is much better odds than the lottery! I am not arguing that people should not get vaccinated, that is their decision. I probably will get vaccinated myself, maybe in about 50- or 60-years’ time, just to be sure we know where all this goes. I will be about 150 by then, and willing to take a risk!
The Therapeutic Goods Administration revealed there have now been 27 vaccine recipients who have suffered from the complication with a further six cases under investigation, as Australia's vaccine rollout continues to come under scrutiny.
So far about 3.8 million Australian's have received at least one dose of either the Pfizer or AstraZeneca jab.
That means only one in every 109,500 people face the risk of blood clots - however just one out of 33 cases have proven fatal.
With only those over 50 permitted to receive the AstraZeneca inoculation, most patients who suffered from blood clots were over 60.
The cases include two woman from New South Wales aged 60 and 82.
A 72-year-old man from Western Australia and a 51-year-old woman.
A 73-year-old woman from Victoria also suffered Thrombosis, along with a 63-year-old man from Queensland.
Last week three more cases were declared probable for blood clots caused by the vaccine.”
“Queensland will not set up a mass vaccination hub to administer the AstraZeneca Covid-19 vaccine to over 50s, the state government has announced.
Instead the state will wait until more Pfizer doses are delivered towards the end of the year before considering hubs similar to those in New South Wales and Victoria.
AstraZeneca doses are still being administered in Queensland via GPs to people over 50.
Premier Annastacia Palaszczuk said planning was under way for a mass hub towards the end of the year.
'Queensland is a big state, it is so decentralised, that so much planning is happening at the moment for that final quarter of the year, when we have more supply in Pfizer, Moderna it is going to ramp up,' she said.
'And I know that Queenslanders are going to go out there in droves when we have all that supply ready.'
It comes as Australian regulators uncover six more cases of rare blood clots linked to the AstraZeneca vaccine, but say they are not unexpected as the rollout expands.
The Therapeutic Goods Administration said four cases were confirmed and the other two were deemed probable.
The new cases include a 57-year-old woman from Victoria, a 53-year-old South Australian man and an 18-year-old woman in Queensland.
The teenager received the vaccine before health advice was changed to say Australians under-50 should get the Pfizer option.
An earlier case of a 79-year-old Victorian man has also been confirmed, while authorities are seeking more information on probable cases in two women aged 71 and 87.”
The Centers for Disease Control and Prevention (CDC) said it had received more than 200,000 reports of adverse effects following vaccination for the Wuhan coronavirus (COVID-19). According to the CDC’s Vaccine Adverse Event Reporting System (VAERS), data from Dec. 14 of last year until May 14 of this year showed 227,805 post-vaccination adverse events. It also noted 943 adverse events among those aged 12 to 17.
Co-managed by the CDC and the Food and Drug Administration (FDA), VAERS is the U.S. government’s tracking system for any events related to vaccination. Its data comes from reports voluntarily submitted to the system. VAERS then publicizes all vaccine injury reports it receives as of a specific date every Friday – usually up to a week before the data becomes public.
VAERS data from Dec. 14 of last year until May 14 of this year showed 227,805 reports of adverse events. These included 18,528 serious injuries and 4,201 fatalities related to COVID-19 vaccination. Of the 93 adverse events in teenagers, 23 were recorded as serious.
The VAERS report followed around 268 million COVID-19 vaccine doses being administered as of May 14. Of that amount, the Pfizer/BioNTech mRNA vaccine comprised 144 million doses. Moderna’s mRNA vaccine made up 115 million doses, while the remaining nine million doses came from Johnson & Johnson. The FDA approved the Pfizer/BioNTech and Moderna vaccine candidates for emergency use in December of last year, while the J&J vaccine got emergency authorization in February of this year.
Furthermore, VAERS data revealed that a number of conditions occurred in people following their COVID-19 vaccination. It showed 2,275 post-vaccination cases of Bell’s palsy – a form of paralysis that affects one side of the face. The condition was reported in 52 percent who got the Pfizer/BioNTech vaccine, 41 percent in Moderna vaccine recipients and nine percent of J&J vaccine recipients.
VAERS also recorded 65,854 reports of anaphylactic reactions – with 51 percent being attributed to the Moderna mRNA vaccine. The Pfizer/BioNTech vaccine was linked to 38 percent of cases while the J&J vaccine was linked to 11 percent of anaphylactic reactions. The system also received 3,758 reports of blood clotting disorders and other similar conditions. While 39 percent of these reports were attributed to the Pfizer vaccine, both Moderna and J&J vaccines constituted 29 percent of these.
Adverse reactions have not dissuaded vaccine makers from targeting younger cohorts.
Despite the more than 900 reports of adverse reactions in teenagers, vaccine manufacturers have pushed to administer more COVID-19 vaccine doses. They appear to be aiming for a younger cohort of children, as evidenced by recent moves to expand their emergency use authorization (EUA).
Pfizer’s COVID-19 vaccine candidate was the first to have its EUA expanded to include teenagers 12 to 15 years old on May 10. Its original EUA issued in December 2020 permitted its use on Americans 16 years and older. According to the U.S. vaccine regulator, the Pfizer/BioNTech mRNA vaccine has met the statutory criteria to amend its EUA, and its known and potential benefits outweigh its possible risks. Acting FDA Commissioner Dr. Janet Woodcock said: “The FDA’s expansion of the [EUA] for the Pfizer/BioNTech COVID-19 vaccine to include adolescents 12 [to] 15 years of age is a significant step in the fight against the COVID-19 pandemic.”
Meanwhile, Pfizer Chairman and CEO Albert Bourla said in a May 10 statement that the FDA’s move “represents a significant step forward in helping the U.S. government broaden its vaccination program and … protect adolescents before the start of the next school year.” The New York-based company also announced its plans to seek EUAs for two cohorts – children aged two to five and children five to 11 years old. In line with this, Pfizer said it is evaluating the safety of its COVID-19 vaccine for children six months to 11 years old.
Later, Moderna said its mRNA COVID-19 vaccine candidate is “safe and effective” for children 12 to 17 years old. The Massachusetts-based company added that the findings came as a result of trials it conducted on younger volunteers in March of this year. According to the Moderna vaccine’s original EUA, Americans 18 years old and above can get the vaccine.
Moderna CEO Stephane Bancel said in a statement: “We are encouraged [that the vaccine] was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection.”