Pfizer-BioNTech’s Covid-19 Vaccine Approved By Australia’s Regulator

Pfizer-BioNTech’s COVID-19 vaccine has been cleared by Australia’s health regulator to be used for immunization in individuals aged 16 years and older.

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This marks the first COVID-19 vaccine approved in Australia. The country’s Therapeutic Goods Administration (TGA) said that the vaccine was found to be in line with the high safety, efficacy and quality standards required for use in Australia. The move comes after the US authorized the vaccine for emergency use to prevent COVID-19 and the European Commission (EC) granted a conditional marketing authorization (CMA) for its deployment.

The TGA provisional approval will be valid for two years. Following the regulatory nod, Pfizer (PFE) and BioNTech can now start the delivery of the first vaccine doses.

The vaccine “has been shown to prevent COVID-19 however, it is not yet known whether it prevents transmission or asymptomatic disease,” the TGA said in a statement.

The Pfizer-BioNTech (BNTX) vaccine contains messenger RNA (mRNA), which is genetic material. Specifically, it contains a small piece of the SARS-CoV-2 virus’ mRNA that instructs cells in the body to make the virus’ distinctive “spike” protein. When a patient receives the vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

Shares of Pfizer have declined 5% over the past year. (See Pfizer stock analysis on TipRanks)

Mizuho Securities analyst Vamil Divan last month reiterated a Buy rating on the stock with a $44 price target (20% upside potential), as he believes that vaccine sales should give Pfizer additional resources to invest in its business, pursue acquisition or licensing opportunities, and return cash to shareholders.

“There seems to be more debate on Pfizer’s ability to distribute the vaccine, given the temperature restrictions associated with the distribution. We remain confident on Pfizer’s ability to execute on this front,” Divan wrote in a note to investors. “We currently give them credit for the >450 million doses that they have already agreed to supply to certain developed countries, but see room for significant upside to our sales and EPS estimates should the vaccine rollout go as planned.”

Meanwhile, the Street’s consensus on the stock is a Hold. That’s based on 8 Holds vs. 2 Buys. Looking ahead, the average analyst price target stands at $42.10, putting the upside potential at about 15% over the next 12 months.

PFE scores an 8 out 10 on TipRanks’ Smart Score system, indicating that the stock has potential to outperform market expectations.