<div>The TGA, like other vaccine safety monitoring programs around the world, closely monitors for specific adverse events known as &#8216;adverse events of special interest&#8217;. This close monitoring helps us to confirm the safety profile of COVID-19 vaccines, particularly with respect to possible side effects that may occur rarely. We conduct analyses to compare the number of reports of these events against the expected rate of events.

Adverse events of special interest reported for the Comirnaty vaccine were:

<ul><li>Anaphylaxis (33 reports)</li>
 <li>Bleeding disorder (7 reports)</li>
 <li>Facial weakness (6 reports)</li>
 <li>Seizure (6 reports)</li>
 <li>Cardiac event (2 reports)</li>
 <li>Loss of sense of taste or smell (2 reports)</li>
</ul>We are continuing to carefully review the reports of possible anaphylaxis following Comirnaty to determine whether they are consistent with true anaphylaxis and whether they may have been caused by the vaccine. Review of these cases indicates that only 11 meet the case definition criteria for anaphylaxis. Further detailed analysis of the observed rate of anaphylaxis in Australia is ongoing. Anaphylaxis remains a very rare side effect of the Comirnaty vaccine.&#160; &#160;

Guidance on the management of possible anaphylaxis remains as per the <a href="https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&amp;t=pi&amp;q=comirnaty">Product Information</a>. Routine vaccination procedures include keeping people under observation for 15 minutes after vaccination and having appropriate medical treatment on hand so that anaphylaxis can be rapidly managed, if it occurs. A second dose of Comirnaty should not be given to those who have experienced anaphylaxis to the first dose.

Bleeding and blood clot disorders, such as stroke, pulmonary embolism and deep vein thrombosis, are being monitored because of a theoretical link with COVID-19 disease. These are common conditions rather than the unusual clotting disorder associated with very low platelets (thrombocytopenia) being investigated in relation to the AstraZeneca COVID-19 vaccine.

Facial weakness has been reported rarely in clinical trials for Comirnaty.

Seizures and cardiac events are being monitored because of a theoretical link with vaccines. They can also occur around the time of immunisation for reasons not related to the vaccine.

The loss of sense of taste or smell is being monitored because of a theoretical link with COVID-19 disease. It may also be a non-specific symptom associated with feeling unwell.

Our review does not suggest an increased risk of any of the above adverse events of special interest with the Comirnaty vaccine.

Further information about Comirnaty can be found in the <a href="https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI?OpenForm&amp;t=cmi&amp;q=Comirnaty">Consumer Medicine Information</a>.
</div>

Regulatory

The TGA, like other vaccine safety monitoring programs around the world, closely monitors for specific adverse events known as ‘adverse events of special interest’. This close monitoring helps us to confirm the safety profile of COVID-19 vaccines, particularly with respect to possible side effects that may occur rarely. We conduct analyses to compa

COVID-19 vaccine weekly safety report - 07-04-2021

Contract Service Directory Profiles
Quantum Packaging Technologies Inc.
Search by
Quantum Packaging Technologies Inc.
Company Headquarters
2153 Lodge Road, Flint, MI, 48532, US
Driving Directions Phone: View Phone
View website
Request more information from Quantum Packaging Technologies Inc.
Request more information from Quantum Packaging Technolog

Categories from Quantum Packaging Technologies Inc.

The narrative behind sustainability is changing.
“When there was any presentation about sustainability, I remember people giggling in the room,” said Thermo Fisher’s Geoffroy Malherbe during a presentation at BPI Europe in Hamburg, Germany in May 2025.
In the past 15 years, sustainability has gone from joke, to afterthought, to goal, to a core busi

Sustainability beyond climate change: How the narrative is evolving in biopharma

Pharmaceutical compounding, particularly in 503A and 503B environments, involves complex formulation and regulatory challenges far beyond academic theory. This summary of our extensive article on this topic—written by industry professionals Paul Pluta RPh, PhD, Alan Mancini RPh, Nishant Thakar, RPh, PharmD, and Varanya Chaiyaperm, RPh, PharmD—disti

The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know

Discover how absorbance-based Process Analytical Technology (PAT) is driving next-generation efficiency in bioprocessing. This webinar explores how integrating PAT into single-use chromatography and Tangential Flow Filtration (TFF) enables real-time monitoring, precise process control, and improved product quality—ultimately reducing variability, p

High Sensitivity PAT in single-use systems for better processing

Samsung Bioepis Co. Ltd. has entered into a license, development and commercialization agreement (DCA) with Harrow for Samsung Bioepis’ ophthalmology portfolio in the U.S. This includes:
BYOOVIZ (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab)
OPUVIZ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept)
The commerci

Samsung Bioepis Taps Harrow for U.S. Eye Biosimilar Portfolio

Recently, the FDA announced a deadline shift, although the agency did so quietly. On June 23, 2025, FDA updated its CDER Nitrosamine Impurity Acceptable Intake Limits webpage to permit manufacturers and sponsors more time to submit required changes for nitrosamine drug substance‑related impurities (NDSRIs) for approved or currently marketed product

FDA Quietly Eases Nitrosamine Reporting Rules Ahead Of August Deadline

Breadcrumb
Home
About the U.S. Pharmacopeia
USP Volunteers
Our independent Volunteer Experts work together in Expert Committees, sharing their diverse knowledge and perspectives. Each Expert Committee focuses on specific areas that span the work we do to improve health. From the drugs and dietary supplements you take to the foods you eat, USP Volun

2025 - 2030 Expert Committees

Thursday, July 17, 2025
The 7th Annual Pharma Manufacturing and Automation Convention 2025 will take place on October 8th and 9th at Hotel Novotel HICC, Hyderabad, uniting industry pioneers, manufacturing leaders, and future-ready teams to rethink how India’s pharmaceutical sector works, grows, and thrives in building of Smart Plants and Smarter Te

7th Annual Pharma Manufacturing & Automation Convention 2025

FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER)
DRAFT QUESTIONS ______________________________________________________________________________
Page 1 of 1
1. DISCUSSION: Discuss the strength of evidence provided by the two phase 3 studies
00071 and 00072, in particular discuss the impact of the discordant results o

Psychopharmacologic Drugs Advisory Committee (PDAC) Meeting

ARTG ID 501790
ARTG Name
Muscle Multivitamin
Product name
Muscle Multivitamin
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
Noumi Nutritionals Pty Ltd
Ingredients
ascorbic acid
Biotin
calcium pantothenate
chromium picolinate
colecalciferol
copper gluconate
cyanocobalamin
d-alpha-tocopheryl acid succinate
folic acid
iro

Muscle Multivitamin

The OGD has been a bit slow in posting approval actions this month. The total number posted through July 15th are 24 full-approval actions and 2 tentative-approval actions. There were none posted yet for July 16th and 17th, but this may just be a delay in processing the actions through the system. Regardless, with half of the month behind us, the n

Unofficial Mid-July 2025 ANDA Approval Actions

French ophthalmology company Nicox (EPA: ALCOX) has signed an agreement with Japan’s Kowa Company (TYO: 7807).
The deal, worth up to 191.5 million euros ($222 million), grants Kowa exclusive rights to develop and commercialize NCX 470, Nicox’s nitric oxide (NO)-donating bimatoprost eye drop, for the lowering of intraocular pressure (IOP) in patient

Kowa and Nicox sign further deal over glaucoma treatment

On July 15, 2025, Sarepta Therapeutics announced a major round of layoffs tied to restructuring its gene therapy and RNA platforms (1). While painful for those directly affected, the move is part of a broader trend: biopharma is entering a phase of strategic contraction. Companies across the United States and globally are cutting staff, shelving pr

What Sarepta's Layoffs, and Others Across Biopharma, Mean for Industry Professionals

GenesisM, a joint venture between Bain Capital Real Estate and Botanic Properties, has broken ground on its 154,000-square-foot Class A biomanufacturing facility at 45 Crosby Drive in Bedford, Massachusetts. The groundbreaking ceremony was attended by members of the project team, town officials and representatives, and local partners in the biotech

GenesisM Breaks Ground on Biomanufacturing Facility in Bedford, MA

FOOD AND DRUG ADMINISTRATION (FDA) Center for Drug Evaluation and Research (CDER)
QUESTIONS ______________________________________________________________________________
Page 1 of 1
1. DISCUSSION: Discuss whether appropriate dosages of belantamab mafodotin have been
identified for the proposed relapsed /refractory population.
2. VOTE: Is the overa

Oncologic Drugs Advisory Committee (ODAC) Meeting

ARTG Name
Advanced Magnesium Powder+ Peach
Product name
Advanced Magnesium Powder+ Peach
ARTG Date
Registration Type
Medicine
Therapeutic good type
Medicine
Sponsor
JSHealth Vitamins Pty Ltd
Ingredients
magnesium amino acid chelate
magnesium citrate
magnesium glycinate dihydrate
Licence category
LI
Licence status
A
Summary
Download PDF

Advanced Magnesium Powder+ Peach

FDA has approved a prefilled syringe version of GSK’s Shingrix, a recombinant zoster vaccine used to prevent shingles, eliminating the need for reconstitution of separate vials prior to administration (1). The newly approved format aims to ease preparation for healthcare professionals, enhancing efficiency and reducing the risk for handling errors

FDA Approves Shingrix Prefilled Syringe to Simplify Vaccine Administration

Thursday, July 17, 2025
Endeavor BioMedicines has received Orphan Drug Designation for its investigational treatment, taladegib (ENV-101), from both the U.S. Food and Drug Administration (FDA) and the European Commission (EC).
Taladegib is a Hedgehog signalling pathway inhibitor that targets a specific receptor to prevent abnormal myofibroblast acc

Endeavor BioMedicines Secures Orphan Drug Designation for Taladegib in Both U.S. and Europe for Idiopathic Pulmonary Fibrosis

This proposed rule would revoke 23 food standards that are no longer necessary to promote honesty and fair dealing in the interest of consumers. We anticipate benefits from some revoked food standards in the form of producer and consumer surplus generated by increased flexibility. We anticipate cost savings from revoking these food standards in the

Proposal to Revoke 23 Standards of Identity for Foods; Preliminary Regulatory Impact Analysis

6 min read
July 16 is celebrated annually as Artificial Intelligence (AI) Appreciation Day. According to the National Day Archives, AI Appreciation Day was created in May 2021 to acknowledge and celebrate the advancements and positive impact of AI across various industries and aspects of life. In the world of Governance, Risk, and Compliance (GRC),

Top 7 Must-Reads on AI in GRC for AI Appreciation Day

In this video clip from our Industry Outlook interview with him back in March 2025, Tore Bergsteiner, managing partner at MAIN5, a European consulting firm specializing in digitally enabled change for life sciences R&D organizations, discusses how AI is increasingly enhancing diagnostics and pathology by enabling early disease detection through adv

AI Boosts Early Disease Detection and Diagnostic Accuracy

Contract development and manufacturing organizations (CDMOs) play an increasingly vital role in the biopharmaceutical industry—evolving from simple capacity providers to strategic, integrated partners. As biopharma pipelines grow more complex and patient needs become more individualized, CDMOs like Rentschler Biopharma are continuously innovating t

Enhancing CDMO Capabilities to Meet Evolving Client Needs

Real Chemistry has made a flurry of leadership appointments, including hiring JJ Schmuckler from VML to fill a newly created role while also making changes at 21Grams and its communications group.
Schmuckler has joined the healthcare marketing and communications group as group president and chief revenue officer. Real Chemistry said the role will r

Real Chemistry finds its formula, adding a trio of new execs as catalysts for change

Qosina, a global supplier of OEM single-use components for the medical and bioprocess industries, has expanded its partnership with the Bioprocess Solutions business unit of Saint-Gobain, a manufacturer of tubing and polymer solutions. This new distribution agreement allows Qosina to enhance its product portfolio to better support its customers’ ev

Qosina Expands Product Portfolio in Partnership with Saint-Gobain

Waltham, MA - Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, today announced an expansion of their strategic partnership with Sanofi to enable additional U.S. drug product manufacturing. The terms of the deal were not disclosed.
Under the agreement, Thermo Fisher will acquire Sanofi’s steriles manufacturing site in R

Thermo Fisher Scientific To Acquire Sanofi's Sterile Fill/Finish Drug Manufacturing And Packaging Facility In New Jersey

Advertise in the PDA News uPDAte & Buyer’s Guide

Contact

Advertise

Other industries

 Join Us for the 20th Anniversary of the PDA Pharmaceutical Microbiology Conference! 

PDA Pharmaceutical Microbiology Conference 2025 

With the increased expectation to adopt modern microbial methods, more technology users are being tasked with evaluating and developing implementation strategies for advanced methods.
There is a desire to couple regulatory guidelines with industry expertise to develop standardized tools that make implementation a less daunting task and one that is