AstraZeneca's vaccine was assessed over two different dosing regimens, with one showing an effectiveness of 90%
Shares of AstraZeneca (AZN) are under pressure on Monday after the company announced results from an interim analysis of clinical trials of AZD1222 in the U.K. and Brazil that showed its COVID vaccine with Oxford has an average efficacy of 70%. This comes after preliminary results from Pfizer (PFE)-BioNTech (BTNX) and Moderna (MRNA) showed their respective COVID vaccines were around 95% effective in testing. Commenting on AstraZeneca's news, SVB Leerink analyst George Porges said he believes the product "will never be licensed in the U.S.," given the design of the company's pivotal trials and the occurrence of severe safety events that resulted in the extended clinical hold on enrollment into the trials in the U.S.
COVID VACCINE INTERIM RESULTS: AstraZeneca announced that results from an interim analysis of clinical trials of AZD1222 in the U.K. and Brazil showed its vaccine with Oxford was "highly effective" in preventing COVID-19, the primary endpoint, and that no hospitalizations or severe cases of the disease were reported in participants receiving the vaccine. There were a total of 131 COVID-19 cases in the interim analysis. One dosing regimen of 2,741 participants showed vaccine efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose at least one month apart, and another dosing regimen of 8,895 participants showed 62% efficacy when given as two full doses at least one month apart. The combined analysis from both dosing regimens resulted in an average efficacy of 70%. All results were statistically significant.
An independent Data Safety Monitoring Board determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine, it added. No serious safety events related to the vaccine have been confirmed. AZD1222 was well tolerated across both dosing regimens. AstraZeneca will now "immediately" prepare regulatory submission of the data to authorities around the world "that have a framework in place for conditional or early approval." The company will seek an Emergency Use Listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.
'NEVER' LICENSED IN THE U.S.: Following the news, SVB Leerink analyst George Porges told investors in a research note that the company is likely to be "roundly criticized" for its disclosure, since the safety disclosure simply stated that no serious safety events related to the vaccine have been confirmed, "which is hardly reassuring." The analyst also claimed that the company "tried to embellish" its results by highlighting a reported 90% efficacy in a relatively small sub-set of subjects in the study who received a modified initial vaccination, followed by a "full dose" four weeks later.
Porges believes that this product "will never be licensed in the U.S.," given the design of the company's pivotal trials and the occurrence of severe safety events that resulted in the extended clinical hold on enrollment into the trials in the U.S. Lastly, he thinks this result rather confounds his thesis that "all spike protein vaccines are created equal." This "manifestly is not the case now," and the result puts into question the outlook for Johnson & Johnson's (JNJ) adenovirus based COVID vaccine as well, he contended.
Meanwhile, AstraZeneca's Ruud Dobber, the Executive Vice President and President of the BioPharmaceuticals Business Unit, said in a Bloomberg TV interview that the comments from SVB Leerink's analyst were "harsh" and he advises to "be patient."
PFIZER-BIONTECH COVID VACCINE: Pfizer and BioNTech announced last week that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study's primary efficacy endpoints. Analysis of the data indicated a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection - the first primary objective - and also in participants with and without prior SARS-CoV-2 infection - the second primary objective - in each case measured from 7 days after the second dose. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%. There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group. To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine.
Last week, both companies announced submission of a request to the U.S. FDA for Emergency Use Authorization of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020. The companies have already initiated rolling submissions with several regulatory agencies around the world, including the EMA and the Medicines & Healthcare Products Regulatory Agency in the U.K., and intend to submit applications to other regulatory agencies worldwide in the coming days. The companies said to be ready to distribute the vaccine candidate within hours after authorization.
MODERNA COVID VACCINE: Earlier this month, Moderna also announced that the independent, NIH-appointed Data Safety Monitoring Board for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5%.
A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases, as defined in the study protocol, in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group. The 95 COVID-19 cases included 15 older adults and 20 participants identifying as being from diverse communities. The interim analysis included a concurrent review of the available Phase 3 COVE study safety data by the DSMB, which did not report any significant safety concerns. A review of solicited adverse events indicated that the vaccine was generally well tolerated. The majority of adverse events were mild or moderate in severity.
PRICE ACTION: In morning trading in New York, shares of AstraZeneca have dropped over 3% to $53.58.