Tag Archives: MHRA

Why Adverse Events of Special Interest Are NOT Side Effects!

Claim : Adverse Events of Special Interest Are Vaccine Side Effects!

People keep sharing a list of 1,291 adverse events in 9 pages of a Pfizer document that was recently released by the FDA.

They are claiming that these are actual side effects of the Pfizer vaccine. Some claimed that this is proof that Pfizer was fully-aware that their vaccine caused those 1,291 side effects.

Some also claimed that these Adverse Events of Special Interest (AESI) are the reason why Pfizer tried to block the release of those documents for 75 years!

Truth : Adverse Events of Special Interest Are Not Vaccine Side Effects!

The truth is those 1,291 adverse events of special interest (AESI) are not side effects of the Pfizer COVID-19 vaccine.

People making these false claims are accidentally misinterpreting OR intentionally misrepresenting what the document said.

And here are the facts you need to know…

Fact #1 : Pfizer Document Was Released Months Ago

These false claims are based on a Pfizer document called “5.3.6 postmarketing experience.pdf“, which the US FDA released to the PHMPT on 17 November 2021.

It apparently took them more than 3 months to read that document, and “discover” the 9 pages of 1,291 adverse events of special interest.

This not only proves that the FDA was right about how much time it takes to read (and redact) 329,000 Pfizer documents, it also shows that the PHMPT does not really need all 329,000 documents within 108 days.

After all, it took anti-vaccination activists almost that long just to read 5 documents! At this rate, it will take them some 16,450 years to read all 329,000 pages related to the Pfizer vaccine approval…

Fact #2 : Pfizer Document Did Not Reveal 1,291 Side Effects

The “List of Adverse Events of Special Interest” (AESI) is NOT a list of side effects caused by the Pfizer mRNA vaccine.

Rather, that was a list of 1,291 potential adverse events that Pfizer was specifically looking for when vaccinated people send in their reports through VAERS or the Yellow Card systems.

Think of it as a shopping list of adverse events that Pfizer wanted their post-authorisation safety teams to look out for.

Even if these adverse events did occur, researchers still need to find out if they actually occurred because of the vaccine, or some other causes.

Fact #3 : Adverse Events Are Not Side Effects

I should now point out that adverse events are not side effects.

Adverse events are “unfavourable” or “unintended” events that happen after vaccination or taking a drug, like having an anaphylactic reaction or getting into a car accident.

All reported adverse events have to be investigated to find out if they are related (anaphylactic reaction) or not (getting into a car accident) to the vaccine or drug that was taken.

Even if an adverse event was “possibly caused” by the vaccine, it must still be confirmed that the vaccine directly caused it, because an anaphylactic reaction (for example) can also occur from a bee sting, or an existing peanut allergy.

Only once an adverse event is confirmed to be caused by the vaccine, is it then a vaccine side effect. Otherwise, it is merely an adverse event, not a side effect.

Fact #4 : AESI List Not Specific To Pfizer Vaccine

The Adverse Events of Special Interest list is not specific to the Pfizer mRNA vaccine. It’s actually stated on Page 16 of the document.

The company’s AESI list takes into consideration the lists of AESIs from the following expert groups and regulatory authorities: Brighton Collaboration (SPEAC), ACCESS protocol, US CDC (preliminary list of AESI for VAERS surveillance), MHRA (unpublished guideline).

The AESI terms are incorporated into a TME list and include events of interest due to their association with severe COVID-19 and events of interest for vaccines in general.

These AESIs are usually specified before clinical trials even begin, although new ones may be added later. Hence, a generic list is used.

Fact #5 : AESI List Includes Irrelevant Adverse Events

We know that this is a generic AESI list, because it included diseases involving other viruses – Herpes, MERS, Varicella; as well as “exposure to SARS-CoV-2” and other “communicable disease”.

The list also included manufacturing and lab test issues, like “Manufacturing laboratory analytical testing issue, Manufacturing materials issue, Manufacturing production issue“.

Even product supply issues were included – “Product availability issue, Product distribution issue, Product supply issue“.

They are obviously not vaccine side effects, nor related in any way to the performance or safety of the vaccine.

Fact #6 : Pfizer Document Showed No New Safety Concerns

The document actually showed that despite monitoring for 1,291 adverse events of special interest, Pfizer found no new risks from the vaccine.

If you read the Discussion and Summary + Conclusion sections, you will see that the data :

did not reveal any “novel safety concerns or risks”
support “a favourable benefit risk profile” of the vaccine

In other words – Pfizer looked for “1,291 potential dangers” associated with vaccines in general, and found NO NEW SAFETY CONCERNS / RISKS.

Don’t risk your life or your family’s lives on the bad science and misinformation promoted by anti-vaccination activists.

Please help me fight fake news, by sharing this fact check with your family and friends!

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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

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Did Malaysia Health Ministry Use Expired COVID-19 Vaccines?

Claim : Malaysia Health Ministry Is Using Expired COVID-19 Vaccines!

This message is going viral on WhatsApp, claiming that the Malaysia Ministry of Health (KKM) is using EXPIRED COVID-19 vaccines.

A million vaccine shots tossed in Indonesia on short expiry date

Our health ministry and Minister must explain why Indonesia is discarding expired vaccine shots while our Health minister is extending the expired period to six months.

It is known that once a vaccine or any medicine is expired it loses its efficacy and should not be given. But our DG and Health Minister on their own accord without any advice from from the vaccine maker decided to extend the expiry period and give it to our people.

Is Malaysian lives so cheap that expired vaccine can be given to our people without fear that it may have adverse effects on the people.?

Truth : Malaysia Is Not Using Expired COVID-19 Vaccines!

This is yet another example of FAKE NEWS circulating on WhatsApp about COVID-19 vaccines.

Malaysia is NOT using expired COVID-19 vaccines, and here are the reasons why…

Fact #1 : Most Expired Vaccines In Indonesia Had Short Shelf Life Left

It is true that more than a million COVID-19 vaccine doses were discarded in Indonesia after they expired. But that was because most of them were donated with just 1-3 months of shelf life left!

On 19 January 2022, Health Minister Budi Gunadi Sadikin told the Indonesian Parliament that about 98% of the 1.1 million doses that were discarded were “donated just 1-3 months away from expiry“.

In other words, it was almost impossible for Indonesia to distribute and use those vaccines before they expired.

Hence, the Indonesian government will be “more selective and only accept doses expiring in three months or longer“.

Fact #2 : COVID-19 Vaccine Shelf Lives Were Too Short

When properly stored, vaccines can last a long time. Most vaccines actually have a shelf life of about three years.

However, vaccine manufacturers have been extraordinarily cautious when it comes to COVID-19 vaccines. Many COVID-19 vaccines ship with shelf lives of only 3 to 6 months!

The key takeaway point is that COVID-19 vaccine shelf lives are extraordinarily short. Many healthcare professionals would call them way too short.

Fact #3 : EUA / EUL Vaccines Do NOT Have Fixed Expiry Dates

The US FDA points out that vaccines authorised for emergency use (EUA / EUL) do NOT have fixed expiry dates.

Vaccines authorized for emergency use – as products that are not approved under a biologics license application and are still being studied under investigational new drug applications– do not have fixed expiry dates.

For those doses that are close to expiry, if they are being held under appropriate conditions for ensuring their integrity for use, they can potentially be quarantined to see if data on new stability studies warrant extension of the initial expiry date according to appropriate policies and procedures.

Fact #4 : Vaccine Shelf Life Extension Is Based On Stability Studies

Vaccine manufacturers can conduct stability studies, to prove that their COVID-19 vaccines remain stable and effective over time.

They can then apply to extend the shelf life of COVID-19 vaccines, which is subject to approval by drug regulatory agencies like the US FDA and the UK MHRA

The shelf life of COVID-19 vaccines will only be extended if stability tests prove that they maintain their potency.

Fact #5 : Vaccine Shelf Life Extension Requested By Manufacturers

The fake news claimed that the Malaysia Health Ministry extended vaccine shelf life on their own accord. That’s complete and utter nonsense.

The vaccine manufacturer must apply for a shelf life extension, and provide their stability study results to prove that their COVID-19 vaccine remain stable and potent beyond the requested shelf life extension.

Fact #6 : Many COVID-19 Vaccines Have Extended Shelf Lives

Many COVID-19 vaccines shipped with very short shelf lives, and have since had them extended, some multiple times.

Pfizer-BioNTech COMIRNATY : Extended to 9 months since 22 August 2021
Moderna Spikevax : Extended to 9 months since 23 December 2021
J&J Janssen : Extended to 4.5 months on 10 June 2021, and then 6 months on 28 July 2021
Sinovac : Extended to 12 months
SII Covishield : Extended to 9 months in March 2021
Bharat Covaxin : Extended to 12 months on 3 November 2021
Sputnik V : Extended to 6 months

Now that you are aware of the facts, please share this fact check with your family and friends, so they won’t get fooled by this fake news!

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Support my work through a bank transfer / PayPal / credit card!

Name : Adrian Wong
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Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

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Why COVID-19 Vaccine Shelf Life Keeps Getting Extended!

COVID-19 Vaccine Shelf Life Is Way Too Short

Based on their experience developing past vaccines, manufacturers have a good idea of how long their vaccines will remain stable and retain their quality and efficacy.

When properly stored, vaccines can last a long time. Most vaccines actually have a shelf life of about three years.

However, vaccine manufacturers have been extraordinarily cautious when it comes to COVID-19 vaccines. Many COVID-19 vaccines ship with shelf lives of only 3 to 6 months!

The key takeaway point is that COVID-19 vaccine shelf lives are extraordinarily short. Many healthcare professionals would call them way too short.

COVID-19 Vaccine Shelf Life Extension Is Normal

The ultra-short shelf life for COVID-19 vaccines have led to criticism that such excessive caution is leading to wastage.

Even while there is a global shortage of vaccines, many doses had to be disposed when they “expired”, even though they are still safe and effective to use.

The WHO has been urging countries to hold onto those “expired doses” while manufacturers are assessing whether their shelf lives can be extended.

The US FDA also points out that vaccines authorised for emergency use do NOT have fixed expiry dates.

Once new stability studies prove that the vaccine remains stable and effective over time, the expiry date of those vaccines can and will be extended.

I should point out that these extended COVID-19 vaccine shelf lives are still very conservative. Perhaps overly conservative.

In fact, we should expect them to keep getting extended as further stability tests show that they do actually last very long.

Which COVID-19 Vaccine Has Extended Shelf Life?

You may be surprised to know this, but the shelf life of many COVID-19 vaccines have extended, sometimes more than once.

So do NOT be alarmed if you are given a dose from a vial with an “expired date“. It does NOT mean that you have been given a “bad vaccine”.

It just means that the vaccine has been proven to last much longer than originally expected.

Pfizer-BioNTech COMIRNATY

The Pfizer-BioNTech COMIRNATY vaccine originally had a 6 month shelf life. That was extended by 3 months, to 9 months on 22 August 2021.

On 16 December 2021, the US FDA also extended shelf life for the COMIRNATY vaccine that uses the Tris buffer to 9 months.

So all existing vaccine doses can be used for an additional 3 months beyond their printed expiry dates, as long as they are stored between -90ºC to -60ºC.

Moderna Spikevax

The Moderna COVID-19 vaccine originally had a 7 month shelf life.

On 23 December 2021, both UK MHRA and Health Canada extended its shelf life by 2 months, to 9 months, as long as it is stored between -25ºC to -15ºC.

The US FDA also extended the shelf life of certain lots by 2 months, to 9 months, as long as they are stored between -50ºC to -15ºC.

J&J Janssen COVID-19 Vaccine

The Janssen COVID-19 vaccine from Johnson & Johnson originally has a 3 month (90-day) shelf life.

The US FDA extended its shelf life to 4.5 months (135 days) on 10 June 2021, and then 6 months (180 days) on 28 July 2021.

All existing vaccine doses can now be used for an additional 1.5 to 3 months (45 to 60 days) beyond their printed expiry dates, as long as they are stored at 2-8ºC.

AstraZeneca Vaxzevria

In May 2021, Health Canada extended the shelf life of about 45,000 AstraZeneca doses by a month, following review of stability data.

It allowed the use of doses with an original expiry date of 31 May 2021, until 1 July 2021.

Otherwise, all AstraZeneca vaccine doses remain with their original shelf life of six months.

Sinovac CoronaVac

The CoronaVac inactivated virus vaccine from Sinovac originally had a 6-month shelf life, which was later extended to 12 months, when it was approved by the WHO.

However, Sinovac appears to give the CoronaVac different shelf lives depending on who’s purchasing their vaccine – 1 year in Malaysia, 2 years in Singapore, and 3 years in Indonesia and Thailand.

Sinopharm BIBP

The Sinopharm BIBP vaccine has a 24-month shelf life, as registered with the WHO. With such a long shelf life, there is no real need for an extension.

CanSino Convidecia

The CanSino Convidecia vaccine has a 24-month shelf life, and remains stable for 60 days at room temperature.

With such a long shelf life, there is no real need for an extension.

SII Covishield

Covishield is a rebranded AstraZeneca vaccine manufactured by the Serum Institute of India, and has the same original 6 month shelf life.

In March 2021, the Drugs Controller General of India (DCGI) extended its shelf life by 3 additional months, to 9 months.

Bharat Covaxin

Covaxin originally had a shelf life of 6 months, but that was extended to 12 months by the Indian Central Drugs Standard Control Organisation on 3 November 2021.

All existing vaccine doses can now be used for an additional 6 months beyond their printed expiry dates, as long as they are stored at 2-8ºC.

Sputnik V

The Russian vaccine – Sputnik V originally had an incredibly short 2-month shelf life at -18ºC.

The Russian Healthcare Ministry then allowed it to be stored for 2 months at 2-8ºC, before later extending it to 6 months when stored at -18ºC to -22ºC.

Please Support My Work!

Support my work through a bank transfer / PayPal / credit card!

Name : Adrian Wong
Bank Transfer : CIMB 7064555917 (Swift Code : CIBBMYKL)
Credit Card / Paypal : https://paypal.me/techarp

Dr. Adrian Wong has been writing about tech and science since 1997, even publishing a book with Prentice Hall called Breaking Through The BIOS Barrier (ISBN 978-0131455368) while in medical school.

He continues to devote countless hours every day writing about tech, medicine and science, in his pursuit of facts in a post-truth world.

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