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Australia TGA bans Pfizer, AstraZeneca brand mentions in COVID-19 vaccine advertising

23:28  23 february  2021
23:28  23 february  2021 Source:   smh.com.au

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Pharmacies, GPs and healthcare organisations will be banned from displaying advertisements identifying whether they are using the Pfizer or AstraZeneca product in the national COVID-19 vaccine rollout.

The Covid-19 Vaccination Hub at Melbourne Airport run by Western Health has opened with Pharmacist Samira Hamidi drawing the vaccine solution into the syringe. The vial will be sent to the Melbourne Museum. PICTURE CREDIT : PENNY STEPHENS / WESTERN HEALTH. MONDAY 22ND FEBRUARY 2021 The AGE News © Penny Stephens / Western Health The Covid-19 Vaccination Hub at Melbourne Airport run by Western Health has opened with Pharmacist Samira Hamidi drawing the vaccine solution into the syringe. The vial will be sent to the Melbourne Museum. PICTURE CREDIT : PENNY STEPHENS / WESTERN HEALTH. MONDAY 22ND FEBRUARY 2021 The AGE NewsÂ

The Therapeutic Goods Administration, the federal body that regulates medical drugs and devices, has released strict guidelines stopping organisations from developing their own ads for coronavirus vaccines.

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COVID - 19 Vaccine AstraZeneca is indicated for active immunisation of individuals ≥18 years old for the prevention of coronavirus disease 2019 ( COVID - 19 ). The use of COVID - 19 Vaccine AstraZeneca should be in accordance with official guidance. As with other vaccines , administration of COVID - 19 Vaccine AstraZeneca should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, and/or low-grade fever should not delay vaccination .

AstraZeneca ’s vaccine has a number of advantages over other leading vaccine candidates: It’s easier to mass produce and store, and it’s also cheaper, at to per dose. That reflects the prices paid by governments like the United States that have placed orders for tens or even hundreds of millions Like the results from Pfizer and Moderna, the data on AstraZeneca ’s vaccine was summarized in a news release . Although the announcement gave efficacy rates , it left out details that would have helped outside researchers independently assess the data: It did not say how many cases of Covid - 19 were

Businesses involved in the rollout are welcome to use government-approved materials to inform the public of vaccine availability but must be careful not to add "the tradename and/or active ingredient of the specific vaccine or other information that might enable consumers to identify the particular vaccine or the manufacturer of the vaccine".

Individuals receiving vaccines will be able to get information on the brand of vaccine they are receiving, but providers will not be able to promote that they are using a particular brand, or compare one product over another.

It comes as the nation's COVID-19 vaccine rollout begins, with the most vulnerable groups including front-line healthcare workers starting to receive doses of imported Pfizer vaccines this week.

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SwissMedic said: "For the vaccine from AstraZeneca , the data available and evaluated to date are not yet sufficient for approval. "In order to obtain additional data on safety, efficacy and quality, data from new studies are required." The move runs counter to the decision made by the European Union's drug watchdog - which Switzerland is not a member - to green-light AstraZeneca 's Covid jab last week. But there is a growing list of EU countries refusing to allow the use of the vaccine in older people.

Australia is taking a "portfolio approach" to vaccinating the nation, with doses set to come from a range of companies including Pfizer, AstraZeneca, and Novavax should that vaccine be successful.

The many options have prompted community comparisons of the vaccines, with Pfizer's phase 3 data suggesting 95 per cent effectiveness, while AstraZeneca's data showed effectiveness of around 70.4 per cent.

Health minister Greg Hunt has been clear that the two vaccines currently approved for use in Australia are both safe and effective, however.

"With both the two initial vaccines, the Pfizer and the AstraZeneca vaccine, the international evidence is that the safety impact for prevention of serious illness, hospitalisation, death has been determined to be up to 100 per cent," he told the ABC on Sunday.

Australia's therapeutic goods laws outlaw the direct advertising of prescriptions and vaccines to the public unless for a government-led public health campaign. In other vaccine campaigns like for seasonal influenza, GPs and doctors are able to let the public know when vaccines will be available but are not allowed to promote or advertise a specific brand of manufacturers of a vaccine.

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The Oxford– AstraZeneca COVID - 19 vaccine , codenamed AZD1222, is a COVID - 19 vaccine developed by Oxford University and AstraZeneca given by intramuscular injection

This announcement contains inside information. 30 December 2020 07:00 GMT. Working with the UK government, first vaccinations to begin early in the New Year. Regulatory interactions continue around the world for next approvals. AstraZeneca ’s COVID - 19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year.

In guidance released this week for COVID-19 vaccines, the regulator warned that any business involved in the rollout of doses must adhere to strict rules about advertising or face fines or court action.

Organisations involved in administering COVID vaccines are not able to create their own advertising and must instead use approved posters and social media materials provided by the government.

They cannot include details that would allow a customer to identify whether the provider is using a certain brand or kind of vaccine, like AstraZeneca or Pfizer. They are also forbidden from making "any comparisons between vaccines", even if these are supported by evidence.

Providers must not advertise with any "statements or the implication that the vaccine offered is superior to other vaccines (e.g. a statement about the efficacy against a particular strain)," the guidelines say.

Infectious diseases social scientist at the University of New South Wales, Dr Holly Seale, said it was important that Australians saw clear information about where to get vaccinated.

"It comes back to things being clear and consistent," she said.

As the COVID-19 vaccine rollout matures, brand names of products will likely become less relevant.

"We know when we talk about a flu vaccine, nobody talks specifically about the type of or brand of product," Dr Seale said.

Europe blocks 250,000 AstraZeneca vaccine doses bound for Australia .
The decision is the first time the European Commission has used its powers to block a shipment and it risks triggering a major diplomatic dispute.The decision is the first time the European Commission has used its powers over whether vaccines manufactured on the continent by Pfizer and AstraZeneca can leave its territory.

usr: 30
This is interesting!