AstraZeneca
AZN
announced that its adenovirus-based coronavirus vaccine candidate, AZD1222, received an authorization for emergency use in the United Kingdom. This is the first approval or authorization for the candidate anywhere in the world and second authorization for any coronavirus vaccine in the United Kingdom. The UK Medicines and Healthcare products Regulatory Agency has authorized use of two full doses of the candidate for the active immunization of individuals 18 years or older. Two doses of the vaccine will be administered with an interval of between four and 12 weeks. First vaccinations in the country are likely to begin early in the New Year
Please note that the United Kingdom was the first country to grant emergency use approval for
Pfizer
PFE
and its partner,
BioNTech
’s
BNTX
mRNA-based COVID-19 vaccine earlier this month. The vaccine is now approved for emergency/temporary/conditional use in more than 40 countries including the United States and 27 EU member countries. Another coronavirus vaccine that has received authorization in the United States and a few other countries is
Moderna
’s
MRNA
mRNA-1273.
The authorization for AZD1222 is based on data from several clinical studies, which showed that the vaccine is safe and effective at preventing symptomatic COVID-19. The vaccine has also demonstrated prevention of severe cases and hospitalizations after the second dose. AstraZeneca had stated that protection from COVID-19 occurred 14 days or more after receiving two vaccine shots.
One dosing regimen (n=2,741) given as a half dose, followed by a full dose at least one month apart demonstrated efficacy of 90%. Another regimen (n=8,895), given as two full doses at least one month apart showed an efficacy of 62%, bringing the average efficacy rate at 70%. Per
FDA’s guidelines
, a vaccine will be considered effective if it is at least 50% effective.
Shares of AstraZeneca were up almost 0.6% following the authorization on Dec 30. This year so far, the company’s shares have risen 0.6% compared with an increase of 2.7% for the
industry
.
AstraZeneca has submitted data from its clinical studies on AZD1222 to support emergency or conditional approval in several countries and the candidate is under review in a few of them. Per a Reuters
report
, the company’s vaccine candidate also received approval for emergency use in Argentina. Per another Reuters
report
, India’s drug regulator met on Wednesday to discuss emergency use approval for the candidate. A decision can be expected soon.
Meanwhile, there seems some confusion with the candidate’s regulatory status in Europe. The European Medicine Agency (“EMA”) stated that the candidate is unlikely to receive any approval in January in Europe as AstraZeneca has not filed for approval per a Reuters
article
. Moreover, the agency stated that only some information about the vaccine is available and that is not enough to warrant a conditional marketing license. However, AstraZeneca defended by stating that it has submitted a full data package with the EMA to support a conditional marketing authorization for AZD1222, per a Reuters
article
. We expect the confusion to be sorted soon and an approval will likely follow.
Although AstraZeneca’s candidate received its first approval, it will likely face stiff competition from Pfizer and Moderna’s vaccine candidates. Both mRNA-based vaccines have achieved much higher vaccine efficacy rates of around 94-95% compared to average efficacy rate of 70% for AZD1222. However, AstraZeneca’s candidate may gain grounds due to logistical advantage as it can be stored, transported and handled at normal refrigerated conditions while Pfizer’s candidate has to be stored and shipped at ultra-cool temperatures.
Zacks Rank
AstraZeneca currently has a Zacks Rank #3 (Hold).
You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
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