New Straits Times

IDENTIFYIN­G ALLERGIES TO VACCINES

MALAYSIA AIRLINES FREQUENT FLYER PROGRAMME It involves personal info of members between March 2010 and June 2019

- DR AMIR HAMZAH ABDUL LATIFF Specialist in Clinical Immunology and Allergy Pantai Hospital, Kuala Lumpur; and Senior Partner to Rhazes Bioscience Partners PLT

DESPITE the speed with which the Covid-19 vaccines were produced, with many more in the pipeline, all would have gone through the many stages in the developmen­t cycle of a vaccine — the explorator­y stage, preclinica­l stage, clinical developmen­t, regulatory review and approval, manufactur­ing, quality control and post-marketing surveillan­ce.

Clinical developmen­t is a threephase process. During Phase 1, small groups of people are given the trial vaccine. In Phase 2, the vaccine is given to people with characteri­stics similar to those for whom the new vaccine is intended, such as age and physical health.

In Phase 3, the vaccine is given to thousands of people and is tested for efficacy and safety. We can all be assured that no shortcuts were taken and we can be confident of the safety and the required efficacy of these vaccines, as determined by the World Health Organisati­on (WHO).

On Dec 8, 2020, the United Kingdom became the first country to administer a fully trialled and tested Covid-19 vaccine to its citizens, followed by other nations, including the United States.

While vaccines often cause adverse reactions, the vast majority of adverse events following immunisati­on (AEFI) are due to the protective immune response induced by the vaccine, not due to allergic reactions.

Anaphylaxi­s as an AEFI is uncommon, occurring at a rate of less than one per million doses for most other vaccines. Therefore, an allergy risk assessment would assist in determinin­g whether an individual should not receive Covid-19 vaccines.

In general, allergic reactions to vaccines are due to adjuvants and other excipients in the vaccine, such as preservati­ves, rather than to the active ingredient itself.

The Pfizer-BioNTech Covid-19 vaccine is not formulated with any food, drugs, or latex, but does contain polyethyle­ne glycol (PEG), which an individual may be allergic to.

Another excipient derived from PEG called polysorbat­e is found in the two viral-vector Covid-19 vaccines from AstraZenec­a and Gamaleya. It has been thought that PEG was the excipient likely to have led to the anaphylaxi­s cases in the US and the UK.

Through risk assessment, stratifica­tion of individual­s with background allergic reactions and through important screening questions they can be categorise­d into higher-, medium-, and lower-risk groups. The questions are:

DO you have a history of severe allergic reaction (anaphylaxi­s) to an injectable drug (intravenou­s, intramuscu­lar or subcutaneo­us) or suppositor­y drug?

DO youhaveahi­storyofase­vere allergic reaction (anaphylaxi­s) to a previous vaccine?

DO you have a history of severe allergic reaction (anaphylaxi­s) to food, drugs (non-injectable), insect sting venom (such as bees or wasps) and latex?

If the answer is “Yes” to questions 1 and 2, then it should be determined whether or not the vaccines or injectable/suppositor­y drugs to be administer­ed do contain PEG or polysorbat­e. If they do contain these excipients, then the person is categorise­d in the higherrisk group and would require further assessment to determine eligibilit­y for the Covid-19 vaccine.

If the vaccines or injectable/suppositor­y drugs of which the person declared experienci­ng previous anaphylaxi­s did not contain PEG or polysorbat­e, then the person is of medium risk.

This would also include a person who answered “Yes” to question 3, and has a history of anaphylaxi­s due to unknown cause. Those categorise­d in the medium-risk group can receive the Covid-19 vaccine with a 30-minute observatio­n period.

Other reactions that is not anaphylact­ic in nature, as well as allergic rhinitis and/or asthma, are categorise­d in the lower-risk group, and may receive the Covid-19 vaccine with at least a 15-minute observatio­n period.

So, increasing public awareness of allergic reactions to vaccines and/ or injectable/suppositor­y drugs and including allergy history in screening questions would assist in identifyin­g people in higher-, medium- or lowerrisk groups.

Hence, all locations involved in the administra­tion of the vaccines must be fully equipped to manage any potential cases of anaphylaxi­s to increase the level of confidence among the public in Covid-19 vaccines, and increase the number of those immunised to provide herd immunity to the nation.

MALAYSIA Airlines experience­d a data security incident which may have compromise­d the personal informatio­n of the members of its Enrich frequent flyer programme between March 2010 and June 2019.

Enrich members were notified by email on Monday that their personal data including name, date of birth, contact informatio­n and frequent flyer data such as number, status and tier level might have been compromise­d.

“Malaysia Airlines was notified of a data security incident at one of its third-party informatio­n technology (IT) service providers which involved some personal data of members of Enrich, Malaysia Airlines’ frequent flyer programme, between the period of March 2010 and June 2019,” the email said.

“The personal data involved in the incident included Enrich members’ names, date of birth, gender, contact details, frequent flyer number, frequent flyer status and frequent flyer tier level. It did not include any informatio­n about itinerarie­s, reservatio­ns, ticketing, or any ID card or payment card informatio­n.”

Malaysia Airlines said in the email it has no evidence that any personal data had been misused, and that “the incident did not disclose any account passwords”.

The national carrier said the incident did not affect its IT infrastruc­ture and systems.

Malaysia Airlines, neverthele­ss, encouraged Enrich members to change their account passwords as a precaution­ary measure.

It will not contact members with regard to updating their personal informatio­n via telephone calls.

It said members who require further guidance on how to protect their personal informatio­n can send enquiries to the data privacy officer at syedzafaru­llah.abduljaafa­r@malaysiaai­rlines.com or anisizzaty.razman@malaysiaai­rlines.com.

When asked whether it would issue a statement, a Malaysia Airlines spokesman said: “Not at the moment. We’ve reached out to customers directly.”

Meanwhile, Synopsys Software Integrity Group technical director Florian Thurmann said many organisati­ons do not see the full picture of what their third-party vendors have done with their critical data and systems.

“For example, if a vendor uses a shared account to access your corporate network, your organisati­on would not be able to determine which of their employees has made a given change in the system,” he said in a statement yesterday.

The lack of visibility, control, and security insight led to a critical blind spot, he added.

“Every organisati­on has the responsibi­lity to ensure its software supply chain vendors meet your cybersecur­ity policy requiremen­ts.”

Thurmann added that even when a data breach has taken place within a vendor’s systems, it is the responsibi­lity of the airline to ensure the privacy of its customers’ data.

“This is not only the case for airlines, but also for organisati­ons across all industries. For this reason, it is critically important to ensure your vendors take security as seriously as your organisati­on, if not more,” he added.

Every organisati­on has the responsibi­lity to ensure its software supply chain vendors meet your cybersecur­ity policy requiremen­ts. FLORIAN THURMANN Synopsys Software Integrity Group technical director

 ?? BERNAMA PIC ?? An allergy risk assessment will ensure a smooth vaccinatio­n campaign.
BERNAMA PIC An allergy risk assessment will ensure a smooth vaccinatio­n campaign.
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