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Moderna’s Spikevax Booster Approved by Swissmedic

Swissmedic has authorized the booster dose of Moderna (MRNA) COVID-19 vaccine, Spikevax.

The dose provided by the American pharmaceutical and biotechnology company can be administered at the 50 µg level to people aged 12 and above. Notably, the dose should be administered after a minimum of six months following the primary vaccinations.

The third dose of Spikevax has also been approved by Swissmedic at the 100 µg dose level for people with a weakened immune system, minimum of 28 days after the second dose.

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CEO of Moderna, Stephane Bancel, said, “We thank Swissmedic for their review and decision. This approval is supported by clinical evidence that a 50 µg booster dose induces a strong immune response against COVID-19. We also appreciate their approval of a third dose of Spikevax for those with weakened immune systems.

“We believe that mRNA vaccines are well positioned to adapt to the evolving epidemiology of SARS-CoV-2.”

Recently, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had also recommended the booster dose of Spikevax in the European Union. The dose was approved to be administered at the 50 µg level for people aged 18 years and above, at least six months after completion of the primary vaccinations.

Additionally, the booster dose had been recommended by the U.S. Centers for Disease Control and Prevention (CDC) following the recent U.S. Food and Drug Administration’s (FDA) emergency use authorization (EUA) for the booster dose in the U.S.

Other Developments

In a separate release, Moderna has announced a new Memorandum of Understanding (MoU) to supply 110 million doses of the COVID-19 vaccine to the African Union. The company is ready to deliver the first 15 million doses in the fourth quarter of 2021, 35 million doses in the first quarter of 2022, and up to 60 million doses in the second quarter of 2022.

Under the company’s plan, it aims to fill doses of its COVID-19 vaccine in Africa as early as 2023, along with the construction of an mRNA vaccine manufacturing facility in Africa.

Moderna targets to produce up to 500 million doses of vaccines each year at this facility.

Analysts Recommendation

Deutsche Bank’s Emmanuel Papadakis initiated coverage of the stock on October 22, with a Sell rating and a price target of $250 (27.8% downside potential).

Papadakis believes that the company needs to either sustain COVID-19 vaccine revenues in the double-digit billions or replace them with other revenue streams, with similar long-term prospects, to justify its current valuation.

According to the analyst, Moderna’s valuation “looks detached from a problematic assessment of reality.”

Overall, the stock has a Hold consensus rating based on five Buys, five Holds, and three Sells. The average Moderna price target stands at $366.56, and implies upside potential of 6% to current levels. Shares have gained 96.8% over the past six months.

Risk Analysis

According to the new TipRanks’ Risk Factors tool, Moderna is at risk mainly from three factors: Tech and Innovation, Finance and Corporate, and Legal and Authority, which contribute 29%, 22% and 19%, respectively, to the total 98 risks identified for the stock.

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