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Janssen Johnson & Johnson

Johnson & Johnson (Janssen) COVID-19 Vaccine Updates

February 26, 2021: The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended approval of an Emergency Use Authorization for the Janssen COVID-19 vaccine by a vote of 22-0 with no abstentions. Following the meeting, the FDA announced that it “has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution.”

Johnson & Johnson announced that it is able to begin delivery of the Janssen vaccine immediately after the EUA is issued and expects to deliver at least 20 million doses of the vaccine to the US by the end of March. Because this vaccine only requires one shot, that translates into 20 million people being fully vaccinated with the Janssen vaccine by the end of March. The Company plans to deliver a total of 100 million doses of the vaccine to the US by July 1, 2021.  

The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on Sunday, February 28th to discuss recommendations concerning utilization and distribution of the Janssen vaccine. On Monday, March 1st, the ACIP will meet to discuss issues concerning COVID-19 vaccines more generally. The full agenda for the meetings on both Sunday and Monday can be found here. The meeting is open to the public and can be viewed via webcast. A link for the webcast can be found here.

February 25, 2021: The U.S. Food and Drug Administration (FDA) will discuss Johnson & Johnson’s (Janssen) request for an emergency use authorization (EUA) for the Company’s vaccine candidate, AD26.COV2.S at a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) tomorrow (February 26, 2021). The meeting is scheduled to begin a 9:00 am EST. A draft agenda for the meeting can be found here. The meeting is open to the public and will be available to watch via the following links: 

February 24, 2021: The US Food and Drug Administration (FDA) has released detailed findings from the Phase 3 trial of the Johnson & Johnson (Janssen) vaccine candidate, Ad26.COV2.S (also known as, JNJ-78436735). The materials available include: a 119-page report prepared by Johnson & Johnson (Janssen), an 8-page addendum to the report, and a 62-page briefing document prepared by the FDA. On pages 12-13, the briefing document concludes: “As such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product under an EUA.” Per the briefing document (page 12), the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Friday, February 26, 2021, “to discuss and provide recommendations on whether based on the totality of scientific evidence available, the benefits of the Janssen Ad26.COV2.S vaccine outweigh its risks for use in individuals 18 years of age and older.” This is the criterion used by the FDA when determining whether to grant an Emergency Use Authorization (EUA) for a vaccine. We plan to report summarized safety and efficacy findings from this study within the next few days.

February 4, 2021: The U.S. Food and Drug Administration (FDA) announced that it will discuss Johnson & Johnson’s request for an emergency use authorization (EUA) for the Company’s vaccine candidate, AD26.COV2.S at a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on February 26, 2021. Background material will be made available to the public by February 24th. We will provide links to those materials on this site as soon as they become available. The meeting will be livestreamed on the FDA’s YouTube, Facebook and Twitter channels. We will provide links to these channels for those who wish to watch.

February 4, 2021: Johnson & Johnson announced that they have submitted an application to the US Food and Drug Administration (FDA) requesting an emergency use authorization (EUA) for their vaccine candidate, AD26.COV2.S. The Company plans to be ready to ship doses of the vaccine immediately after receiving authorization from the FDA. The Johnson & Johnson vaccine is a potentially important addition to the other vaccines currently available in the United States because it is estimated to be 85% effective in preventing severe COVID-19 after a single dose and it can be shipped using normal distribution channels. The Company estimates that the vaccine can be stored a standard refrigerator temperatures (36-46º F) for up to three months. 

January 29, 2021: Johnson & Johnson announced findings from the ENSEMBLE trial evaluating the safety and efficacy of a single dose of their vaccine candidate, AD26.COV2.S. This study was conducted in several countries, including the United States and South Africa. In the United States, a single dose of this vaccine was found to be 72% effective in preventing moderate to severe COVID-19 beginning 28 days after vaccination. The effectiveness of the vaccine in preventing moderate to severe COVID-19 was 66% in Latin America and 57% in South Africa. (When averaged across all study sites the vaccine was found to be 66% effective in preventing moderate to severe COVID-19 and 85% effective in preventing severe COVID19. No deaths related to COVID-19 were reported in the vaccine group, whereas 5 COVID-19-related deaths occurred in the placebo group.) The Company also reported that the vaccine was well-tolerated and that no safety concerns were identified.

The ENSEMBLE trial included nearly 44,000 participants, with 34%  of participants over age 60. In their press release, the Company stated: “The study enrolled 44% (N=19,302) of participants in the United States, 41% (N=17,905) in Central and South America (Argentina, Brazil, Chile, Colombia, Mexico, Peru) and 15% (N=6,576) in South Africa.” The table below shows the race/ethnicity of study participants, both globally and for the US only.

Race/Ethnicity Globally US Only
White/Caucasian 59% 74%
Hispanic/Latinx 45% 15%
Black/African American 19% 13%
Native American 9% 6%
Asian 3% 1%

The Company reported that vaccine efficacy was mostly consistent across racial/ethnic and age groups, and across different variants of the virus and regions studied. In South Africa, about 95% of the COVID-19 cases observed among study participants were due to infection with a variant of the original SARS-CoV-2 virus from the B.1.351 lineage. It is unclear if the lower efficacy observed among South African participants was due to the vaccine providing less protection against these variants.

The Company is planning to file a request for an emergency use authorization (EUA) with the US Food and Drug Administration (FDA) in early February. This request will contain detailed findings from the study. Based on experience with the Pfizer-BioNTech and Moderna vaccines, we anticipate that the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to review the EUA request in mid to late February. Materials submitted by Johnson & Johnson and the results of independent analyses conducted by FDA staff should be available to the public about two days before the VRBPAC meeting. 

If the EUA is granted, the Company expects to be able to meet all 2021 supply commitments. Notably, Johnson & Johnson was part of Operation Warp Speed and received $456 million for research to develop a vaccine and $1 billion to deliver 100 million vaccine doses.

In addition to the ENSEMBLE trial described above, Johnson & Johnson is conducting the ENSEMBLE 2 trial which is studying the safety and efficacy of a two-dose regimen of the AD26.COV2.S vaccine. Enrollment of study participants in ENSEMBLE 2 began on November 15, 2020.

December 17, 2020: Johnson & Johnson announced that enrollment in the ENSEMBLE study has been completed. This study is evaluating a single dose of the vaccine candidate AD26.COV2.S. About 45,000 people have been enrolled in the study. The company expects to be able to report interim findings from the study by the end of January 2021. However, this will depend on the rate at which people in the study get moderate/severe COVID-19. (The protocol for this study states that the first interim analyses will be performed when 20 people in the study have developed moderate/severe COVID-19. If the vaccine is effective, most of these cases will occur among people who received the placebo vaccine.)

If the data support the safety and efficacy of the AD26.COV2.S vaccine, the company expects to submit an application for an Emergency Use Authorization (EUA) to the US Food and Drug Administration in February. If a EUA is approved, AD26.COV2.S would become the third vaccine approved for use in the US and it would be the first to require only a single dose. It is important to remember, however, that no safety or efficacy data have yet been reported from the study. 

The Company intends to file for U.S. Emergency Use Authorization (EUA) in early February and expects to have product available to ship immediately following authorization. It expects to share more information on specifics of deployment as authorizations are secured and contracts are finalized. The Company’s anticipated manufacturing timeline will enable it to meet its 2021 supply commitments, including those signed with governments and global organizations.

November 15, 2020: Johnson & Johnson announced a second global Phase 3 study of its candidate vaccine, Ad26.COV2.S. This vaccine is also known as JNJ-78436735. This new study will evaluate a 2-dose vaccine regimen. The new study is called ENSEMBLE 2. See Table 1 under Phase 3 Studies for more details about the study.

October 23, 2020: Johnson & Johnson announced that it is preparing to resume recruitment in the United States in its Phase 3 trial of the candidate vaccine, Ad26.COV2.S. This vaccine is also known as JNJ-78436735. This trial is called the ENSEMBLE trial. The temporary pause was triggered when one study participant developed a serious medical event. The nature of the event was not disclosed due to patient privacy concerns. The company reported that no clear cause for the event could be identified and that there was no evidence that the vaccine caused the event. The Data Safety and Monitoring Board (DSMB) overseeing this trial determined that it was safe to resume recruitment. The U.S. Food and Drug Administration (FDA) agreed with this decision. The company is in discussion with other regulatory agencies around the world to resume the study in other countries.

October 12, 2020: Johnson & Johnson paused its Phase 3 trial of the investigational vaccine, Ad26.COV2.S. This trial is called the ENSEMBLE trial. Until the trial is resumed, no new participants will be enrolled in the trial and no participants in the trial will be vaccinated. In large clinical trials, it is not unusual for some study participants to experience major medical events and these events often happen by chance. When a serious adverse event happens, the trial is paused to allow the Data Safety and Monitoring Board (DSMB) overseeing the trial, as well as regulatory agencies like the FDA, an opportunity to review data from the trial and determine if it is safe to resume. In their press release, Johnson & Johnson also provided information to clarify the difference between a “Study Pause” and a “Regulatory Hold”.

September 23, 2020: Johnson & Johnson announced the launch of its Phase 3 trial of the investigational vaccine, Ad26.COV2.S. This trial is called the ENSEMBLE trial. In the press release, Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson stated:  “We greatly value the collaboration and support from our scientific partners and global health authorities as our global team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorization in early 2021.”

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AstraZeneca Oxford

AstraZeneca Oxford COVID-19 Vaccine (AZD1222) Updates

  • January 5, 2021: The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom published the full Public Assessment Report for the AstraZeneca vaccine candidate, AZD1222. It can be accessed here.
  • December 30, 2020: The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom granted temporary approval for the AstraZeneca vaccine candidate, AZD1222, to be used in the UK. The conditions for the approval are available here. The Information for Healthcare Professionals sheet contains information from the interim analyses reported on November 23, 2020. To the best of our knowledge, findings from the final efficacy analyses are not yet available.
  • November 30, 2020: Since AstraZeneca released the findings from the first interim analysis for its COVID-19 vaccine candidate, AZD1222, on November 23rd, it has been reported that the most promising finding announced by the company (90% efficacy among people who received a half dose of the vaccine, followed by a full dose one month later) occurred by mistake. No one in the study was supposed to receive a half dose of the vaccine before the full dose. A company spokesperson quoted by Reuters said that all participants were supposed to receive two full doses of the vaccine. However, that does not match the information the company provided in ClinicalTrials.Gov. According to ClinicalTrials.Gov, the study being conducted in the United Kingdom was designed to test: (1) a single full dose of the vaccine; (2) a single full dose of the vaccine, followed by a half dose “booster” 4-6 weeks later; (3) two full doses of the vaccine, separated by a 4-6 week period; and (4) a single half dose vaccine for children age 5-12. The study being conducted in Brazil was designed to test: (1) a single full dose of the vaccine and (2) two full doses of the vaccine, separated by a 4-12 week period.In addition, after the company released its interim findings, it was discovered that only participants who were 55 years old or younger had received the half dose vaccine. So, we have no way to know if the vaccine would have been equally effective in older adults, who are most likely to develop severe COVID-19.Astra-Zeneca did not initially disclose the dosing mistake, contending that it didn’t matter whether the dosing change was done on purpose or not. However, it does matter!Scientific studies are designed to test specific hypotheses. These hypotheses must be stated at the start of the study, before any data are collected. If the scientists discover other interesting things when they are conducting the study, they use these discoveries to develop new hypotheses and design new studies to test them. That is simply how the scientific process works. For this reason, the 90% efficacy reported for people who received the half dose vaccine should be viewed with skepticism.Notably, AstraZeneca has not published the full protocols for the studies being conducted in the United Kingdom or Brazil. Hopefully, they will make these available to the public soon. It would also be helpful to see the interim findings broken down by: (1) country (United Kingdom/Brazil), (2) age groups identified in the ClinicalTrials.Gov records for these studies, and (3) each dosing regimen examined.Despite these concerns, the interim analyses suggest that the 2 full dose regimen of AZD1222 may reduce the risk of developing symptomatic COVID-19 by 62%. This is better than the minimal threshold of 50% efficacy recommended by the Food and Drug Administration (FDA). Although this level of efficacy is lower than the vaccines developed by Pfizer and Moderna, the AstraZeneca vaccine can be stored at normal refrigerator temperatures (36-46° F) for at least six months and is less expensive to manufacture than the Pfizer and Moderna vaccines. Therefore, the AstraZeneca vaccine still has the potential to play a significant role in bringing the COVID-19 pandemic under control.
  • November 23, 2020: AstraZeneca announced results from an interim analysis of its COVID-19 vaccine candidate, AZD1222. The analysis included data from studies being conducted in the United Kingdom and Brazil. A total of 131 COVID-19 cases were included in the interim analysis. The company reported findings from two different dosing regimens. Among participants who received a half-dose of the vaccine, followed by a full dose one month later, vaccine efficacy was 90%. Among participants who received a full dose of the vaccine followed by a full dose one month later, vaccine efficacy was 62%. These findings are difficult to interpret because data from two countries were combined and different dosage regimens are being tested in these countries. It would be helpful to have the efficacy estimates reported separately for each country. In addition, in both countries, the studies are also evaluating the efficacy of a single dose regimen. No data concerning the effectiveness of the single dose regimen were reported.  
  • November 5, 2020: First results from Phase 3 trials for the AstraZeneca Oxford COVID-19 vaccine, AZD1222, are expected in the fourth quarter of 2020. (Note: This link opens to a slide presentation in pdf format. Information about AZD1222 appears on Slides 25 and 31.)
  • October 23, 2020: Clinical trials for the AstraZeneca Oxford COVID-19 vaccine candidate, AZD1222, resumed in the United States after the Food and Drug Administration (FDA) completed review of all safety data from trials being conducted around the world and determined that it was safe to resume the trial.
  • October 2, 2020: A Phase I/II clinical trial for the AstraZeneca Oxford COVID-19 vaccine candidate, AZD1222, resumed in Japan, with approval of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Trials had previously been resumed in the United Kingdom, Brazil, South Africa, and India.
  • September 12, 2020: Clinical trials for the AstraZeneca Oxford coronavirus vaccine candidate, AZD1222, resumed in the United Kingdom after the Medicines Health Regulatory Authority (MHRA) determined that it was safe to do so.
  • September 9, 2020: A participant in a clinical trial for the AstraZeneca Oxford COVID-19 vaccine candidate, AZD1222, developed an unexplained illness. The illness was identified as part of standard procedures used in all clinical trials to ensure the safety of study participants. Immediately after the illness was identified, the developers voluntarily paused all clinical trials of the vaccine being conducted around the world. In an interview with NBC News, Dr. Francis Collins, Director of the National Institutes of Health, identified the illness as transverse myelitis and explained that the illness may not have been caused by the vaccine. In large clinical trials, illnesses often happen by chance. This pause in the study will allow data safety committees and regulatory agencies like the FDA an opportunity to review data from the trials to determine if it is safe to continue enrolling participants.
  • August 31, 2020: Enrollment began in the US Phase 3 trial for the AstraZeneca Oxford COVID-19 vaccine candidate, AZD1222.  Phase 3 trials of AZD1222 had begun previously in the UK, Brazil and South Africa.

Around the World

  • October 1, 2020: The European Medicines Agency (EMA) announced that it had started a “rolling review” of data from studies involving AstraZeneca’s vaccine candidate, AZD1222. The EMA is the equivalent of the Food and Drug Administration in the United States. According to the EMA announcement, “A rolling review is one of the regulatory tools that EMA uses to speed up the assessment of a promising medicine or vaccine during a public health emergency. Normally, all data on a medicine’s effectiveness, safety and quality and all required documents must be submitted at the start of the evaluation in a formal application for marketing authorisation. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies, before a formal application is submitted. Once the CHMP decides that sufficient data are available, the formal application should be submitted by the company. By reviewing the data as they become available, the CHMP can reach its opinion sooner on whether or not the medicine or vaccine should be authorised.”