TGA: Approved | Paxlovid | Lagevrio

TGA Approved Paxlovid and Lagevrio: A New Weapon in Australia's Fight Against Covid-19

Australia is soon to be equipped with a new weapon in the battle against Covid-19, but early shortages are expected. Oral medications Paxlovid and Lagevrio, recently approved by the Therapeutic Goods Administration (TGA), are anticipated to be hard to come by in the first few months.

The TGA has granted provisional approval for Pfizer's Paxlovid and Merck Sharp and Dohme's Lagevrio for use in the country. The federal government has ordered approximately 800,000 doses of the antiviral pills, with the first shipments due to arrive soon.

Initial Availability and Supply Constraints

According to Dr. Karen Price, President of the Royal Australian College of General Practitioners (RACGP), there is a global shortage of these medications, which will affect supply in Australia. Dr. Price indicated that initial availability is expected within the month, but larger shipments may take a few months to arrive.

Furthermore, the medications will not be available until they are listed on the Pharmaceutical Benefits Scheme (PBS) and subsidized by the Australian government. This could delay their accessibility to the general public.

Who Can Benefit from Paxlovid and Lagevrio?

The antiviral pills are designed to be taken within five days of symptom onset to prevent severe illness in mild to moderate cases. However, they are not suitable for everyone and are not a substitute for vaccination.

Dr. Price emphasized that the medications are specifically intended for individuals at high risk of developing severe Covid-19, such as those with pre-existing health conditions. Vaccination remains the most effective way to prevent serious illness or hospitalization due to Covid-19.

Regulatory Approvals and Conditions

The provisional approval of Paxlovid and Lagevrio in Australia is subject to strict conditions, including ongoing data submission to the TGA regarding the long-term safety and efficacy of the medications.

Both drugs have also received conditional marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and emergency use authorization from the US Food and Drug Administration (FDA). Health Canada approved Paxlovid earlier this year.