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Moderna (MRNA) to Supply More Doses of COVID-19 Vaccine to Canada
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Moderna, Inc. (MRNA - Free Report) announced that Canada's government has exercised its option to increase the supply order by 20 million doses for its novel mRNA-based coronavirus vaccine candidate, mRNA-1273. Following the increased supply agreement from the Canadian government, Moderna will now provide a total of 40 million doses of mRNA-1273 upon potential approval.
The company has already initiated the rolling review process for mRNA-1273 with Health Canada. Moderna remains on track to ship its COVID-19 vaccine to the country as soon as December if regulatory approval is granted this month.
Shares of Moderna were up 3.4% in pre-market trading on Tuesday following the announcement of the news. In fact, the stock has skyrocketed 715.6% so far this year compared with the industry’s increase of 5.8%.
Moderna has been actively engaged in securing supply deals for the vaccine candidate and has signed agreements with several countries including the United States, United Kingdom, Japan, Canada and the European Commission. The company remains focused on making its vaccine available in multiple countries.
We note that Moderna has filed to the FDA, requesting Emergency Use Authorization (“EUA”) for mRNA-1273. The company has also requested the European Medicines Agency for Conditional Marketing Authorization, where its regulatory application seeking approval for mRNA-1273 is under rolling review.
Notably, the FDA has scheduled an advisory committee meeting on Dec 17 to discuss Moderna’s EUA. The EMA is expected to meet with the company on Jan 12 to discuss its regulatory submission. Moderna’s candidate achieved an efficacy rate of 94.1% in primary efficacy analysis. Importantly, it showed 100% effectiveness in preventing severe cases of COVID-19.
Earlier this month, Pfizer (PFE - Free Report) and its Germany-based partner, BioNTech (BNTX - Free Report) received a temporary authorization for their mRNA-based coronavirus vaccine candidate, BNT162b2, for emergency use in the United Kingdom. The companies have also filed for emergency use in the United States, EU and India. Moreover, rolling submissions for BNT162b2 are underway in several other countries.
Meanwhile, AstraZeneca (AZN - Free Report) , in partnership with Oxford University, is evaluating an adenovirus-based coronavirus vaccine candidate, AZD1222, in late-stage studies. AZD1222 was, on an average, about 70% effective in preventing COVID-19, per interim data released from late-stage studies.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Moderna (MRNA) to Supply More Doses of COVID-19 Vaccine to Canada
Moderna, Inc. (MRNA - Free Report) announced that Canada's government has exercised its option to increase the supply order by 20 million doses for its novel mRNA-based coronavirus vaccine candidate, mRNA-1273. Following the increased supply agreement from the Canadian government, Moderna will now provide a total of 40 million doses of mRNA-1273 upon potential approval.
The company has already initiated the rolling review process for mRNA-1273 with Health Canada. Moderna remains on track to ship its COVID-19 vaccine to the country as soon as December if regulatory approval is granted this month.
Shares of Moderna were up 3.4% in pre-market trading on Tuesday following the announcement of the news. In fact, the stock has skyrocketed 715.6% so far this year compared with the industry’s increase of 5.8%.
Moderna has been actively engaged in securing supply deals for the vaccine candidate and has signed agreements with several countries including the United States, United Kingdom, Japan, Canada and the European Commission. The company remains focused on making its vaccine available in multiple countries.
We note that Moderna has filed to the FDA, requesting Emergency Use Authorization (“EUA”) for mRNA-1273. The company has also requested the European Medicines Agency for Conditional Marketing Authorization, where its regulatory application seeking approval for mRNA-1273 is under rolling review.
Notably, the FDA has scheduled an advisory committee meeting on Dec 17 to discuss Moderna’s EUA. The EMA is expected to meet with the company on Jan 12 to discuss its regulatory submission. Moderna’s candidate achieved an efficacy rate of 94.1% in primary efficacy analysis. Importantly, it showed 100% effectiveness in preventing severe cases of COVID-19.
Earlier this month, Pfizer (PFE - Free Report) and its Germany-based partner, BioNTech (BNTX - Free Report) received a temporary authorization for their mRNA-based coronavirus vaccine candidate, BNT162b2, for emergency use in the United Kingdom. The companies have also filed for emergency use in the United States, EU and India. Moreover, rolling submissions for BNT162b2 are underway in several other countries.
Meanwhile, AstraZeneca (AZN - Free Report) , in partnership with Oxford University, is evaluating an adenovirus-based coronavirus vaccine candidate, AZD1222, in late-stage studies. AZD1222 was, on an average, about 70% effective in preventing COVID-19, per interim data released from late-stage studies.
Zacks Rank
Moderna currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>