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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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Moderna

Moderna COVID-19 Vaccine Updates

 

Summary of findings from Phase 3 trial evaluating the Moderna COVID-19 vaccine is available here. Data from this study were analyzed by the US Food and Drug Administration (FDA) before it issued an emergency use authorization for this vaccine.

Studies in Children

  • February 25, 2021: Moderna announced that it has completed enrollment of 3,000 adolescents aged 12-17 in a Phase 2/3 study evaluating the safety and efficacy of the mRNA-1273 vaccine in this age group. All participants have been recruited in the United States. This study is called the TeenCOVE study, after the original COVE study conducted in people age 18 and over. The company is planning to begin a third study (KidCOVE) focusing on children between the ages of 6 months and 11 years in the near future.

 

Development of Variant-Specific Vaccines

  • February 24, 2021: Moderna announced that it has completed manufacture of a vaccine candidate tailored to protect against the B.1.351 variant of the SARS-CoV-2 virus first identified in the Republic of South Africa. The variant-specific vaccine is called mRNA-1273.351. The Company has shipped doses of the variant-specific vaccine to the National Institute of Allergy and Infectious Disease (NIAID) at the National Institutes of Health (NIH). NIAID will perform a small clinical trial (Phase 1) to determine if the mRNA-1273.351 vaccine boosts immunity against the South African variant. Moderna envisions offering the mRNA-1273.351 vaccine as a booster for people who have already received the original vaccine or making a multivalent vaccine that would include the original vaccine and the variant-specific vaccine in a single shot. This type of multivalent (or combined) vaccine strategy is currently used for vaccines to prevent many other conditions, including influenza.


Efficacy Against Different Strains of SARS-CoV-2

  • January 26, 2021: Moderna announced results from a recently conducted in vitro study demonstrating that the Moderna vaccine, mRNA-1273, is likely to be effective in preventing infection from variant strains of the SARS-CoV-2 virus identified in the United Kingdom (called B.1.1.7) and South Africa (called B.1.351). Both of these variants of the SARS-CoV-2 virus have caused concern because they appear to be more contagious than the original virus. Although Moderna believes that the mRNA-1273 vaccine will provide protection against all variants of the SARS-CoV-2 virus identified to date, the recent study found that the mRNA-1273 vaccine, produces fewer neutralizing antibodies in response to the South African variant of the virus than in response to the original virus. This suggests than the vaccine may provide less protection against the South African variant of the virus. Therefore, the company has started to evaluate strategies to enhance vaccine efficacy. These include: determining if an additional booster dose of the mRNA-1273 vaccine increases the production of neutralizing antibodies against emerging virus strains including the B.1.351 variant and testing the efficacy of a modified vaccine (mRNA-1273.351) against the B.1.351 variant.

 Timeline for FDA Application and Availability of Vaccine to the Public

  • December 17, 2020: The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that an emergency use authorization (EUA) be issued for the Moderna candidate vaccine, mRNA-123. The committee voted on the following question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” The vote was 20-Yes, 0-No, and 1-Abstention. (Note: Although Moderna recently started enrolling children age 12-17 into the trial, data from these participants are not yet available. That is why the question was limited to individuals age 18 or older.) It is likely that the FDA will issue the EUA tomorrow. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on Saturday and Sunday of this week to vote on recommended uses of the Moderna COVID-19 vaccine under the EUA. The agenda for this meeting can be accessed here. The meeting will be live streamed and can be viewed here.
  • December 15, 2020: The US Food and Drug Administration (FDA) has released detailed findings from the Phase 3 trial of the Moderna candidate vaccine, mRNA-1273. An 84-page document prepared by Moderna is available here and a 7-page addendum to this document is available here.  A 54-page document prepared by the FDA is available here. On page 11 of this document the FDA states: “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” (Emergency Use Authorization). On page 12, the FDA states that the vaccine is proposed “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.” We plan to report summarized safety and efficacy findings for the full sample and for different subgroups within the next few days.
  • November 30, 2020: Moderna announced that it plans to submit a request to the US Food and Drug Administration (FDA) today for an Emergency Use Authorization (EUA) for its candidate vaccine, mRNA-1273. In their primary efficacy analyses, 196 cases of laboratory-confirmed symptomatic COVID-19 occurred. Of these 185 occurred among people who received the placebo vaccine and 11 occurred among those tho received the mRNA-1273 vaccine, resulting in an estimate of vaccine efficacy of 94.1%. Of the 196 cases of symptomatic COVID-19 that occurred, 30 were classified as SEVERE COVID-19, all of which occurred in the placebo group.
  • November 11, 2020: Moderna reported that it has enough data for the first interim analysis from the Phase 3 trial of its experimental COVID-19 vaccine (mRNA-1273). It had submitted trial data to the independent board monitoring its trial, a sign that results could be announced shortly. The company said it expects this first interim analysis to include “substantially more than 53 cases,” which was the targeted trigger point for the analysis.
  • November 11, 2020: Dr. Anthony Fauci predicted that Moderna could have data from the Phase 3 trial of its COVID-19 vaccine (mRNA-1273) anywhere between “a couple of days” to “a little more than a week”.
  • October 22, 2020: According to a CNN report, Moderna’s president, Dr. Stephen Hoge, stated that “if all the stars align”, Moderna will apply for an emergency use authorization (EUA) for its COVID-19 vaccine (mRNA-1273) from the Food and Drug Administration (FDA) in early December 2020.

    Milestones to Reach Before FDA Submission

    53 study participants must develop laboratory-confirmed, symptomatic COVID-19.

    At least 40 of these 53 people (75%) must be in the control group (that is, they received a placebo vaccine).

    At least 15,000 study participants (50%) must be followed for at least 8 weeks after receiving their second dose of vaccine to assess possible side effects.

     
  • September 30, 2020: Moderna CEO, Stéphane Bancel told the Financial Times that Moderna will not seek an emergency use authorization for its COVID-19 vaccine (mRNA-1273) from the Food and Drug Administration (FDA) before November 25, 2020.

Interim Results

  • November 30, 2020: Moderna announced that it has completed the primary efficacy analysis for the Phase 3 study (known as the COVE study) testing its COVID-19 vaccine candidate, mRNA-1273.
    • A total of 196 people in the study developed laboratory-confirmed, symptomatic COVID-19. Of these, 185 had received the placebo vaccine and 11 had received the mRNA-1273 vaccine. Thus, they estimated that the vaccine reduces the risk of getting symptomatic COVID-19 by 94.1%.
    • In addition, a total of 30 people in the study developed severe COVID-19. All 30 had received the placebo vaccine.
    • No serious safety concerns have been reported.
    • Today, the Company will submit materials requesting a Emergency Use Authorization (EUA) for the mRNA-1273 vaccine from the United States (US) Food and Drug Administration (FDA). The Company expects these materials to be reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 17, 2020.
    • The Company expects to have about 20 million doses of the mRNA-1273 vaccine available in the United States by the end of 2020 and remains on track to manufacture 500 million to 1 billion doses globally in 2021.
  • November 16, 2020: Moderna announced results of the first interim analyses for its COVID-19 vaccine candidate, mRNA-1273. They reported that the vaccine was 94.5% effective in preventing laboratory-confirmed, symptomatic COVID-19. This study is known as the COVE study. More than 30,000 participants in the US are enrolled in the study. About half of these participants received the mRNA-1273 vaccine and the other half received a placebo vaccine.  95 participants in the study developed laboratory-confirmed COVID-19. Of these, 90 had received the placebo vaccine and 5 had received the mRNA-1273 vaccine. Of the 95 people in the study who developed COVID-19, 11 had severe COVID-19. All of the people who developed severe COVID-19 had received the placebo vaccine. No significant safety concerns were reported. The most common “severe” side-effects were: fatigue (9.7%), muscle pain (8.9%), and joint pain (5.2%). A “severe” side effect was defined as one that prevented a participant from doing routine daily activities on at least one day following an injection.
  • November 16, 2020: Moderna announced new data showing that its COVID-19 vaccine candidate, mRNA-1273, is more stable than originally estimated. The new data show that the vaccine remains stable:
    • At standard freezer temperatures (-4º F) for 6 months,
    • At standard refrigerator temperatures (36º to 46º F) for 30 days, and
    • At room temperature for up to 12 hours.

This better than expected stability will make it easier to distribute the vaccine to sites where it can be administered. It will also make it easier for doctors, nurses and pharmacists to store and administer the vaccine. In addition, the greater stability will likely result is less waste. The vaccine will come in vials than contain 5 doses. Once a vial is removed from the freezer, health care providers will have 30 days to use all 5 doses.

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Moderna

Novavax COVID-19 Vaccine Updates

Interim Study Findings and Timeline for FDA Application

  • January 28, 2021: Novavax presented information concerning the status of the Phase 3 study of its vaccine candidate, NVX-CoV2373, being conducted in the United States and Mexico. This study is testing a 2-dose regimen, with the doses administered 3 weeks apart. The Company plans to enroll a total of 30,000 study participants, with two-thirds of the participants receiving the NVX-CoV2373 vaccine.
    • As of January 27, 2021, a total of 16,748 people had been enrolled. The Company expects enrollment to be completed during the first half of February 2021 and that preliminary results may be available by April 2021.
    • The Company expects the NVX-CoV2373 vaccine to be approved for emergency use first in the United Kingdom (UK) based on findings from the study reported below. However, the Company is also discussing the types of data needed to obtain an emergency use authorization in other countries around the world, including the United States.
    • In the United States, the Food and Drug Agency could consider approving the NVX-CoV2373 vaccine for emergency use based on data from the UK study. In this case, emergency use authorization could be granted before the end of March 2021. 
    • Novavax is part of Operation Warp Speed and obtained $1.6 billion for vaccine research and the manufacture of 100 million vaccine doses.
  • January 28, 2021: Novavax announced the results of interim analyses from the Phase 3 study of its vaccine candidate, NVX-CoV2373, being conducted in the United Kingdom (UK). This study is testing a 2-dose regimen, with the doses administered 3 weeks apart. The study enrolled more than 15,000 people between the ages of 18 and 84.
    • In the interim analyses, the vaccine was nearly nearly 90% effective in preventing symptomatic COVID-19, beginning 7 days after the second dose. A total of 62 cases of symptomatic COVID-19 were observed (56 in the placebo group and 6 in the NVX-CoV2373 group). Only one participant developed severe COVID-19. This participant was in the placebo group.
    • Of the 62 cases observed, 32 were caused by the UK variant of the SARS-CoV-2 virus and 24 were caused by the original virus first identified in Wuhan, China. (In the remaining 6 cases, the virus has not been sequenced.) Vaccine efficacy was estimated at 95.6% against the original virus and 85.6% against the UK variant.
    • No safety concerns were identified.
    • The final analyses will be conducted when a total of 100 cases have been observed.
  • November 9, 2020: Novavax announced that its COVID-19 vaccine candidate, NVXCoV2373, has been granted Fast Track Designation by the US Food and Drug Administration (FDA). The Fast Track process is designed to streamline FDA review of new drugs and vaccines that may help treat or prevent a serious health problem. The goal is to get drugs and vaccines to patients as quickly as possible without compromising safety.

Participant Enrollment

  • October 27, 2020: Novavax announced that 5,500 people have been enrolled in the Phase 3 trial being conducted in the United Kingdom to test its COVID-19 vaccine candidate, NVXCoC2373. (For more information about this study, see Table 3 under Phase 3 studies.) The company increased the planned number of study participants from 9,000 to 15,000 and expects to have all participants enrolled by the end of November 2020. This is an event-driven study. The first interim analysis will be performed when at least 66 people in the study have developed laboratory-confirmed symptomatic COVID-19. With the increase in the number of study participants, the company expects to be able to conduct their first interim analysis as soon as the first quarter (January-March) of 2021.

Around the World

  • November 4, 2020: Novavax announced that it has signed a non-binding agreement with the Australian Government to supply 40 million doses of the company’s vaccine candidate, NVXCoC2373. The vaccine could be delivered as soon as the first half (January-June) of 2021. The agreement depends on whether the vaccine is shown to be safe and effective in ongoing Phase 3 trials and is approved for use by Australia’s Therepeutic Goods Administration (TGA). The TGA is equivalent to the Food and Drug Administration (FDA) in the United States. Novavax has established similar agreements with the governments in other countries, including: the United States, the United Kingdom, and Canada. They have also established agreements with partners to distribute the vaccine in Japan, South Korea, and India.
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Gamaleya Sputnik V

Sputnik V Vaccine Updates

Interim Findings

  • November 24, 2020: The Gamaleya Center and the Russian Direct Investment Fund announced that their COVID-19 vaccine candidate is 91.4% effective in preventing COVID-19 starting 28 days after participants receive the first dose of the vaccine (7 days after the second dose). The data reported included a total of 18,794 study participants. Of these, 14,095 received the Sputnik V vaccine and 4,699 received a placebo vaccine. A total of 39 cases of laboratory-confirmed COVID-19 were identified, 8 among people who received the Sputnik V vaccine and 31 among people who received a placebo vaccine. In addition, the vaccine is over 95% effective when only counting cases beginning 42 days after the first dose (21 days after the second dose). These findings are consistent with immunity from COVID-19 increasing over time following the second vaccination. However, we still do not know how long immunity lasts. No serious safety concerns have been reported.
    • Several unanswered questions remain:
      1. We do not know how long immunity lasts.
      2. The investigators appear to be including all cases of laboratory-confirmed COVID-19, not just those that cause the patient to have symptoms. This is different than studies being conducted in the United States, where the primary focus is on symptomatic COVID-19. Thus, we do not know if the Sputnik V vaccine reduces the risk of developing symptomatic COVID-19.
      3. We do not know if the Sputnik V vaccine reduces the risk of developing severe COVID-19, being hospitalized, or dying.
      4. We do not believe that the developers of this vaccine have made their full study protocol available online. This is important because all analyses conducted should be planned from the beginning of the study. Publishing the protocol helps to ensure that the developers do not change their analyses in a way that biases their findings.
  • November 11, 2020: The Gamaleya Center and the Russian Direct Investment Fund announced results from the first interim analysis of their COVID-19 vaccine candidate, Sputnik V. They report that the vaccine is 92% effective in preventing COVID-19 starting 21 days after the first dose of the vaccine. The trial included data from over 16,000 study participants. Among these individuals, a total of 20 people developed laboratory-confirmed COVID-19. The announcement does not say how many of these 20 people had received the Sputnik V vaccine.
    • Several unanswered questions remain:
      1. We do not know how long immunity lasts.
      2. The investigators appear to be including all cases of laboratory-confirmed COVID-19, not just those that cause the patient to have symptoms. This is different than studies being conducted in the United States, where the primary focus is on symptomatic COVID-19. Thus, we do not know if the Sputnik V vaccine reduces the risk of developing symptomatic COVID-19.
      3. We do not know if the Sputnik V vaccine reduces the risk of developing severe COVID-19, being hospitalized, or dying.
      4. We do not believe that the developers of this vaccine have made their full study protocol available online. This is important because all analyses conducted should be planned from the beginning of the study. Publishing the protocol helps to ensure that the developers do not change their analyses in a way that biases their findings.

Manufacturing

  • November 27, 2020: The Russian Direct Investment Fund and Hetero (a major generic pharmaceutical company in India) have reached an agreement to make 100 million doses of the Sputnik V vaccine per year beginning in 2021.
  • November 13, 2020: The Russian Direct Investment Fund has reached an agreement with GL Rapha (a major bio-tech company in South Korea) to make 150 million doses of the Sputnik V vaccine per year, beginning in December 2020. The vaccine will be distributed globally.
  • September 30, 2020: The Russian Direct Investment Fund has reached an agreement with Pharco (a major pharmaceutical group in Egypt) to supply 25 million doses of the Sputnik V vaccine to Egypt. This will give 25% of the population of Egypt access to this vaccine.
  • September 29, 2020: The Russian Direct Investment Fund has reached an agreement with Trinity Pharmaceutical (a major pharmaceutical distributor in Nepal) to supply 25 million doses of the Sputnik-V vaccine to Nepal. This will give 90% of the population of Nepal access to this vaccine.
  • September 25, 2020: The Russian Direct Investment Fund has reached an agreement with LAXISAM (a major pharmaceutical company in the Republic of Uzbekistan) to supply up to 35 million doses of the Sputnik V vaccine to Uzbekistan in 2020-2021.
  • September 16, 2020: The Russian Direct Investment Fund (RDIF) has reached an agreement with Dr. Reddy’s Laboratories (a major pharmaceutical company in India) to cooperate on clinical trials and distribution of the Sputnik V vaccine in India. After the vaccine is approved for use in India, the RDIF will supply 100 million doses of the vaccine, potentially beginning in December 2020.
  • September 11, 2020: The Russian Direct Investment Fund has reached an agreement with the State of Bahia (Brazil) to supply up to 50 million doses of the Sputnik V vaccine, potentially beginning in November 2020. The agreement assumes that the vaccine is approved for use in Brazil by regulatory agencies.
  • September 9, 2020: The Russian Direct Investment Fund has reached an agreement with Landsteiner Scientific pharmaceutical company to supply up to 32 million doses of the Sputnik V vaccine to Mexico. This will give 25% of the people in Mexico access to the Sputnik V vaccine.
  • August 26, 2020: The Russian Direct Investment Fund has reached an agreement with SK-Pharmacy (a pharmaceutical company in Kazakhstan) to supply the Sputnik V vaccine to Kazakhstan. The press release does not say how many doses will be provided.
Categories
BioNTech Pfizer

BioNTech SE (Pfizer) COVID-19 Vaccine Updates

Summary of findings from the Phase 3 trial evaluating the Pfizer-BioNTech COVID-19 vaccine  is available here.  Data from this study were analyzed by the US Food and Drug Administration (FDA) before it issued an emergency use authorization for this vaccine.

 

Efficacy Against Different Strains of SARS-CoV-2

  • January 20, 2021: Pfizer announced results from a recently conducted in vitro study demonstrating that the Pfizer-BioNTech vaccine, BTN162b2, is likely to be effective in preventing infection from the mutant strain of the SARS-CoV-2 virus first identified in the United Kingdom. This strain, called B.1.1.7, has caused concern because it appears to be more contagious than the original SARS-CoV-2 virus. The press release includes a link to a report describing the methods used in this study as well as study findings.

Post-Marketing Surveillance

  • January 19, 2021: The Norwegian Medicines Agency (NOMA) issued a statement about the 23 deaths that occurred among severely frail nursing home residents following coronavirus vaccination. The statement stresses that: “Fatal incidents among these severely frail patients following vaccination do not imply a causal relationship between COVID-19 vaccination and death.”  As of January 18, 2021, 48,680 people in Norway have been vaccinated. Many of those vaccinated are nursing home residents. This group was prioritized to receive the vaccine, because nursing home residents are at greatest risk for severe COVID-19. In the statement, Dr. Sara Viksmoen Watle, Senior Physician at the Norwegian Institute of Public Health explained:

“When we vaccinate the eldest and sickest who often have several underlying conditions we expect high mortality in this population. Hence, we also expect deaths following vaccination. We do not yet know if these deaths are due to the vaccine or other causes, but we cannot exclude that common side effects may have led to a more severe course for some patients. The 23 deaths occurred within six days after vaccination. We will examine these events in relation to the expected number of deaths among the nursing home populations. The Norwegian Medicines Agency and the Norwegian Institute of Public Health are now carrying out in-depth analyses. So far, there are no statistical analyses that indicate that coronavirus vaccination has had an increased risk of death among those vaccinated.” 

  • January 15, 2021: The Norwegian Medicines Agency (NOMA) has advised doctors in Norway to carry out extra evaluation of very sick, elderly patients before administering the Pfizer-BioNTech vaccine. This advisory was in response to the deaths of 23 frail, elderly nursing home residents in Norway who died within 6 days of receiving the vaccine. NOMA has investigated 13 of these deaths and found that vaccine side effects such as fever and diarrhea may have contributed to the deaths. They emphasize that these types of side effects are NOT dangerous for younger, fitter people. More information can be found in: a 1-page paper published in the British Medical Journal and a NOMA report issued on January 15, 2021.

The Pfizer-BioNTech vaccine is currently the only COVID-19 vaccine approved for use in Norway and more than 20,000 doses have been administered over the past few weeks. Nursing home residents have been prioritized to receive the vaccine, because they are at greatest risk for severe COVID-19. An average of 400 nursing home residents die each week in Norway. Therefore, the reported deaths following vaccination could be coincidental. Norway is continuing to monitor reports of adverse effects following vaccination, but has not changed its vaccination strategy.

Timeline for FDA Application and Availability of Vaccine to the Public

  • December 12, 2020: The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will meet today to vote on recommended uses of the Pfizer-BioNTech COVID-19 vaccine candidate, BTN162b2, under the emergency use authorization (EUA) issued yesterday by the US Food and Drug Administration (FDA). The meeting is scheduled to begin at 11:00 am (EST) and adjourn at 3:00 pm (EST). The full agenda can be accessed here. The meeting is being live streamed and can be viewed here.
  • December 11, 2020: The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine candidate, BTN162b2. This authorization allows the vaccine to be used in individuals 16 years of age and older. As part of the EUA, Pfizer is required to submit a safety report each month that includes information about adverse events and newly identified safety concerns. If these reports are made available to the public, we will provide information from the reports on this site. The FDA Fact Sheet for healthcare providers administering the vaccine can be accessed here and a Fact Sheet for patients and caregivers can be accessed here.
  • December 10, 2020: The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that an emergency use authorization be issued for the Pfizer-BioNtech candidate vaccine, BNT162b2. The committee voted on the following question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?” The vote was 17-Yes, 4-No, and 1-Abstention. Those who voted No were concerned that there is limited information available for use of the vaccine in adolescents age 16 and 17. It is likely that the FDA will issue the EUA within the next few days.
  • December 8, 2020: The US Food and Drug Administration (FDA) has released detailed findings from the Phase 3 trial of the Pfizer-BioNtech candidate vaccine, BNT162b2. A 92-page document prepared by Pfizer is available here. A 53-page document prepared by the FDA is available here. On page 11 of this document the FDA states: “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” (Emergency Use Authorization). On page 12, the FDA states that the vaccine is proposed “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.” We plan to report summarized safety and efficacy findings for the full sample and for different subgroups (based on age, gender, race, country) within the next few days.
  • November 20, 2020: Pfizer announced that it plans to submit a request to the US Food and Drug Administration (FDA) today for an Emergency Use Authorization (EUA) for its candidate vaccine, BNT162b2. If the FDA approves the EUA, the company said that it may be possible to start vaccinating high-risk people in the US by the middle to end of December 2020. The FDA has stated previously that it plans to have an open meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) before approving a EUA for any COVID-19 vaccines. This committee meeting is planned for Dec. 10, 2020. The FDA plans to make background materials for this meeting available on December 8, 2020. We anticipate that these materials will include much more detailed findings from the Phase 3 study testing BNT162b2. In addition, the Centers for Disease Control and Prevention (CDC) has scheduled a meeting for its Advisory Committee on Immunization Practices (AICP) on November 23, 2020. This Committee develops recommendations for the use of vaccines in the US. However, it does not have the authority to issue a EUA.
  • November 9, 2020: Pfizer announced that it expects to submit for an Emergency Use Authorization (EUA) for their mRNA-based COVID-19 vaccine candidate, BNT162b2, from the Food and Drug Administration (FDA) in the third week of November. This is based on when they expect to have two months of follow-up safety data for at least 15,000 study participants, as required by the FDA.
  • November 9, 2020: Pfizer currently expects to manufacture up to 50 million vaccine doses for the global market by the end of 2020 and up to 1.3 billion doses by the end of 2021. This assumes that the vaccine is approved for marketing by regulatory agencies (such as the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe).
  • October 19, 2020: According to the Pfizer COVID-19 website, the company expects to manufacture 100 million vaccine doses for the global market by the end of 2020 and up to 1.3 billion doses by the end of 2021. This assumes that the vaccine is approved for marketing by regulatory agencies (such as the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) in Europe).
  • October 16, 2020: In an open letter, Pfizer Chairman and CEO Albert Bourla announced that Pfizer may know whether their vaccine is effective by the end of October. The exact date is uncertain because the data from the study will not be analyzed until 32 study participants have gotten laboratory confirmed symptomatic COVID-19. According to the study protocol, the vaccine would be considered effective if at least 26 of these 32 participants were in the control group.

    Milestones to Reach Before FDA Submission

    Expected Date When Milestone Will Be Reached

    32 study participants must develop laboratory-confirmed, symptomatic COVID-19.

    End of October

    At least 26 of these 32 people (81%) must be in the control group (that is, they received a placebo vaccine).

    End of October

    At least 15,000 study participants (50%) must be followed for at least 8 weeks after receiving their second dose of vaccine to assess possible side effects.

    Third Week of November

    Manufacturing data must demonstrate the quality and consistency of the vaccine production process.

    Before the Third Week of November

 

Vaccine Authorized for Use in the UK

  • December 2, 2020: The Commission on Human Medicines (CHM) in the United Kingdom (UK) approved emergency use of Pfizer’s vaccine candidate, BNT162b2, following review by the Medicines and Healthcare products Regulatory Agency (MHRA). The CHM also released a document for health care providers in the UK that contains information from clinical trials testing BNT162b2. As reported previously, among study participants who were age 16 or older, a total of 170 developed laboratory-confirmed symptomatic COVID-19.  Of these 170 study participants, 162 had received the placebo vaccine and 8 had received BNT162b2. Thus, the vaccine appears to reduce the risk of getting COVID-19 by 95.0% (95% confidence interval 90.3% to 97.6%). The vaccine appears to be equally effective in adults age 65 and older, who made up 21.8% of the sample. However, it is not clear if people over the age of 85 were enrolled in the study. (By study design, only cases of COVID-19 that occurred at least 7 days following receipt of the second vaccine dose were counted. This allowed time for immunity to develop following vaccine administration.)

    Safety data are based on 19,067 study participants (9,531 who received the BNT162b2 vaccine and 9,536 who received the placebo vaccine). The most common side effects were: pain at the injection site (> 80%), fatigue (> 60%), headache (> 50%), muscle pain (> 30%), chills (> 30%), joint pain (> 20%), and fever (> 10%). The intensity of these side effects was usually mild or moderate and resolved within a few days after having the vaccine administered.

    • Pregnancy, Breast-feeding:  Due to the lack of data, it was originally recommended that the BNT162b2 vaccine not be administered during pregnancy. However, this recommendation was changed. The current professional labeling states that use of this vaccine during pregnancy “should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.”
    • Children: Data have only been reported for study participants who were age 16 or older. The vaccine is currently being studied in children age 12-16, so more data may be released soon.
    • Duration of Immunity: We also do not know how long protection from COVID-19 will last after BNT162b2 is administered.

Results from Primary Efficacy Analyses

  • November 20, 2020: Pfizer submitted materials to the US Food and Drug Administration requesting an emergency use authorization for it COVID-19 vaccine candidate, BNT162b2. The FDA announced that the materials will be reviewed by its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10, 2020. This meeting will be live streamed on the agency’s YouTube, Facebook and Twitter channels. The FDA plans to make background materials for this meeting available on December 8, 2020. We anticipate that these materials will include much more detailed findings from the Phase 3 study testing BNT162b2.
  • November 18, 2020: Pfizer announced that it has completed the primary efficacy analyses of data from the Phase 3 study testing its COVID-19 vaccine candidate, BNT162b2. As planned before the start of data collection, the primary efficacy analyses were conducted after 164 study participants developed laboratory confirmed symptomatic COVID-19. The company reported that a total of 170 people had reached this study endpoint. Of these, 162 had received the placebo vaccine and 8 had received the BNT162b2 vaccine. Thus, they estimated that the vaccine is 95% effective in preventing COVID-19. The vaccine also appears to help prevent severe COVID-19. A total of 10 people in the study developed severe COVID-19. Of these, 9 had received the placebo vaccine. The company reported no serious safety concerns. The most common  “severe” side-effects reported were: fatigue (3.8%) and headache (2%). A “severe” side effect was defined as one that prevented a participant from doing routine daily activities on at least one day following an injection. Finally, the company reported that the findings were similar across groups that differed in age, gender, race, and ethnicity. Although these findings are very promising, several important questions remain. For example, we do not know if the vaccine reduces the risk of hospitalization or death. We also do not know if the vaccine prevents asymptomatic COVID-19. This is important because individuals with asymptomatic COVID-19 can infect others who can then develop more serious disease. We also do not know how long protection lasts and only limited data are available concerning side-effects the vaccine may have. Finally, data reported by the company still needs to be reviewed by experts who are not involved with the study

Interim Results

  • November 9, 2020: Pfizer announced that its mRNA-based COVID-19 vaccine candidate, BNT162b2, has demonstrated over 90% efficacy in preventing laboratory-confirmed symptomatic COVID-19 among participants with no prior history of SARS-CoV-2 infection. These results are based on planned interim analyses. A total of 94 study participants have developed laboratory-confirmed, symptomatic COVID-19 to date. (Cases of COVID-19 are only counted if they occurred at least one week after the second dose of the vaccine was administered. This gives the vaccine time to work.) The company reported that no serious safety concerns have been observed in the trial. We will provide more detailed information as soon as it is available to the public. The company will conduct their final efficacy analyses when at least 164 study participants have developed laboratory confirmed cases of COVID-19.  The company also plans to conduct analyses to see if the vaccine helps prevent severe COVID-19. Although these findings are very promising, several important questions remain. For example, we do not know if the vaccine reduces the risk of severe COVID-19, hospitalization, or death. We also do not know if the vaccine prevents asymptomatic COVID-19. This is important because individuals with asymptomatic COVID-19 can infect others who can then develop more serious disease. We also do not know how long protection lasts and only limited data are available concerning side-effects the vaccine may have. Finally, data reported by the company still needs to be reviewed by experts who are not involved with the study.

Participant Enrollment

  • November 9, 2020: Pfizer announced that the trial of their mRNA-based COVID-19 vaccine candidate, BNT162b2, has enrolled 43,538 participants and 38,955 have received the second dose of the vaccine, which is given three weeks after the first dose. About 30% of participants recruited in the United States have racially and ethnically diverse backgrounds. The Pfizer COVID-19 vaccine website provides more information about the race/ethnicity of study participants and the percentage of participants between the ages of 56 and 85 years.
  • October 19, 2020: According to the Pfizer COVID-19 vaccine website, they have enrolled 39,862 study participants in their clinical trial to date and 34,601 of these participants have received the second dose of vaccine. (Note: The vaccine being tested in this study requires 2 doses, given 3 weeks apart.) The Pfizer COVID-19 vaccine website includes a table showing the race/ethnicity of study participants and the percentage of participants between the ages of 56 and 85 years.
  • October 13, 2020: Pfizer announced that it has gotten approval from the Food and Drug Administration (FDA) to enroll children as young as 12 years old in their clinical trial.
  • September 12, 2020: Pfizer announced that it plans to increase enrollment in their clinical trial from about 30,000 study participants up to about 44,000 participants. They also plan to expand the eligibility criteria for the study to include adolescents who are 16 or 17 years old.

 

Around the World

  • November 20, 2020: Pfizer announced that several countries have started a rolling review of its vaccine candidate, BNT162b2. These include: Australia, Canada, Japan, the European Union, and the United Kingdom.
  • October 6, 2020: The European Medicines Agency (EMA) announced that it had started a “rolling review” of data from studies involving Pfizer’s vaccine candidate, BNT162b2. 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.”