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Among multiple vaccine candidates worldwide, the next arsenal for COVID-19 is likely to be a single-dose Ad26.COV2.S vaccine under development by Johnson & Johnson / Janssen and specializes in infectious diseases. The house is predicting.
And this week we are approaching with promising interim measures Phase 1 / 2a test resultsPublished online on January 13th New England Journal of Medicine..
A single dose of Ad26.COV2.S was associated with S-binding and neutralizing antibodies in more than 90% of participants. This finding was observed in both adults aged 18-55 years and participants aged 65 years and older, as well as in participants who received low or high dose vaccination.
The results also suggest a sustained vaccine response. “Takeaway message [includes] High neutralizing antibody responder rate for a single dose of Ad26.COV2.SCOVID-19 vaccine candidate. In addition, these reactions and antibody titers have been found to be stable for at least 71 days, “said Dr. Hanneke Schuitemaker, senior research author and global director of viral vaccine discovery and translation medicine at Johnson & Johnson in Leiden, the Netherlands. It was. Medscape Medical News.
If a Johnson & Johnson single-dose product obtains an FDA Emergency Use Authorization (EUA), the overall number of vaccinations available can be significantly increased. Less stringent storage requirements — only regular refrigeration against the need to freeze the Pfizer / BioNTech and Moderna COVID-19 vaccines — are another potential benefit. The Ad26.COV2.S vaccine can be refrigerated at 2 ° -8 ° C (36 ° -46 ° F) for up to 3 months.
“Phase 1-2 study data on the J & J vaccine. If it works like the mRNA option, there are substantial benefits,” said Jeremy, a physician in the emergency department at Brigham and Women’s Hospital and Harvard University. Dr. Faust tweeted. January 13th.
Phase 1-2 trial data on the J&J vaccine.
— Jeremy Faust MD MS (ER physician) (@jeremyfaust) January 14, 2021
Unlike the Pfizer / BioNTech and Moderna messenger RNA vaccines, Johnson & Johnson products are recombinant non-replicating adenovirus serotype 26 encoding the full-length, stabilized SARS-CoV-2 spike (S) protein (S). Ad26) Vector.
Phase 3 efficacy / safety results pending
Under normal circumstances, Phase 3 test results are not expected within a few weeks of Phase 1 / 2a test results. However, the urgency of the COVID-19 pandemic accelerated the vaccine development process, so preclinical studies were conducted simultaneously rather than sequentially.As a result, Phase 3 interim results for the Johnson & Johnson vaccine are expected within a few weeks, with company executives Told Reuters Deployment is proceeding smoothly towards March.
“We would like to report data from ENSEMBLE, the first phase 3 study testing the preventive effect of a single dose of Ad26.COV2.S by the end of this month or early February,” said Schuitemaker. I am.
Meanwhile, the interim results of the multicenter, randomized, double-blind, and placebo-controlled trials were positive during Phase 1 / 2a.
Carlos Del Rio, Executive Associate Dean of Emory University in Grady, Atlanta, Georgia, said in a tweet on January 13: “The data are very promising and support a single vaccination approach that makes this vaccine unique. I will. “
Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine | The @NEJM publishes today the J&J #Covidvaccine phase 1/2. Data is highly encouraging and supports the single inoculation approach that makes this vaccine unique. https://t.co/LvlPCc1dZX
— Carlos del Rio (@CarlosdelRio7) January 13, 2021
“We encourage COVID vaccine data from J & J released today. Solid antibody, CD4 T cell, and CD8 T cell response — a wonderful triple star of vaccine immune response! And safe!” Lahoya Immunity in Lahoya, California Dr. Shane Crotti, a vaccine scientist and professor at the Institute of Science, tweeted.
1/ Encouraging COVID vaccine data from J&J published today. Solid antibody, CD4 T cell, and CD8 T cell responses–a nice trifecta of vaccine immune responses to see! And safe! https://t.co/7FhyzzqMs5 pic.twitter.com/LYFEvIE9Yq
— Shane Crotty (@profshanecrotty) January 14, 2021
Initial results of over 800 participants
At baseline in the Phase 1 / 2a trial, 2% of the younger group and 1% of the 65+ group were seropositive for SARS-CoV-2S-specific antibodies.
A total of 402 people in the younger age cohort and 403 in the 65+ group received the Johnson & Johnson vaccine for the first time. Many participants also received a second dose of another study, ENSEMBLE 2, 56 days later. It was designed to compare the safety and efficacy between single and double dose regimens. The outcome of the trial is still pending.
Single doses were associated with a higher incidence of requested systemic adverse events in the higher vaccinated group. They also found that grade 3 adverse events diminished with increasing age.
Pain at the injection site on the day or the next day of vaccination was the most common local reaction. The pain usually went away within 24 hours. Fever was reported by 15% of the low-dose vaccine group and 39% of the high-dose cohort. Malaise, headache, And myalgia were the most common grade 1 or 2 requested systemic adverse events reported.
Five serious adverse events were reported, including four that researchers considered unrelated to vaccination: hypotension, bilateral Renal stone disease, Legionella pneumonia, and a case of exacerbation Multiple sclerosis.. A serious vaccine-related adverse event was a fever that resulted in hospitalization on suspicion of COVID-19. The patient recovered within 12 hours.
“These data support previous experience with vaccine candidates based on the Ad26 viral vector platform in the younger age group. Similar performance in the elderly is promising,” said Schuitemaker.
Researchers say the potential limitation of the Phase 1 / 2a trial is “lack of representatives from minority groups.” Johnson & Johnson is working to improve the diversity of study participants “on the groups most likely to be affected by the COVID-19 pandemic.”
AstraZeneca / Oxford Vaccine Status
The AstraZeneca / Oxford AZD1222 vaccine under development was approved for use in the United Kingdom on December 30. Approval was subsequently made. UK Public Health Services said the country is facing an “unprecedented” level of infectious disease, Reported by the BBC.. AstraZeneca applied for approval from the European Medicines Agency earlier this week. This has the potential to expand its use throughout Europe.
Vaccine status remains uncertain in the United States. Phase 3 trials in the United States, which began in August, were suspended for approximately six weeks in September and October after adverse events in UK volunteers stopped studies worldwide. On October 23, the FDA allowed researchers to continue the study with approximately 40,000 participants.
In clinical trials, half the amount of AstraZeneca vaccine More effective than the full dose, 90% vs. 62%, but some irregularities in the investigation need further investigation.
The AstraZeneca vaccine, like Johnson & Johnson products, is delivered to cells by adenovirus, but is designed to be given twice at 28-day intervals, similar to the Moderna mRNA vaccine dosing schedule.
Need for speed and more doses
Regardless of which vaccine product obtains EUA in the United States, many experts agree to deploy the COVID-19 vaccine to date. There was a problemWhen the case has risen to record levels, and perhaps more relevant to the logistics of vaccination than dose production.
“Large doses are being manufactured. We hope that December 20 million, January 40 million, February 80 million, and J & J will be added to the count soon. What’s missing is vaccination. The number of weapons not received. The freezer does not get a COVID. It does not need all. These vaccines, “said Daniel Griffin, Medical Doctor, Infectious Diseases Expert in Port Washington, New York, on January 12. Tweeted.
Lots of doses being manufactured. In December 20 million, January 40 million, February 80 million and J&J hopefully soon to add to the count. The shortage is the number arms not getting vaccinated. Freezers do not get COVID. They do not need all those vaccines. https://t.co/ka3uBDcT2Q
— Daniel Griffin MD PhD (@DanielGriffinMD) January 12, 2021
“Unfortunately, due to the lack of resources in this current distribution phase, the deployment is not going smoothly,” said Dr. Andrew T. Pavia, MD, Head of Pediatric Infectious Diseases, University of Utah School of Medicine. Stated. During a media briefing hosted by the Infectious Diseases Society of America (IDSA) today in Salt Lake City.
“We are concerned about the mismatch between the number of people allegedly eligible and the amount of vaccine being distributed,” he said.
Complicating the deployment is a directive from US Secretary of Health and Welfare Alex Azar. Let’s start vaccination for everyone People over 65 years old and with underlying illness.
Expanding distribution to 15% of Americans in this age group is a major challenge, Pavia said. “There are enough vaccines to vaccinate 40 million people by the end of this month. There is a major disruption, which causes many problems.”
“One of the biggest problems is trying to implement this mass vaccination program in the midst of the biggest surge we’ve ever seen,” said Julie Vaishampayan, Chairman of the IDSA Public Health Commission. MD and MPH mentioned at the briefing session. “People will come in very long lines” if public health authorities do not have enough time to plan vaccinations for more people.
Vaishampayan began sharing analogies from colleagues in an attempt to increase access to vaccination without proportionally increasing the available dose. “”
Pavia emphasized that infectious disease experts “know effective countermeasures.” Not using masks, physical distances, or hand hygiene is like “knowing that really good shark repellents are available in the summer. Dive into the bloody waters while great white sharks are swimming. .. “
World Health Organization (WHO) officials agreed. “Vaccines are coming online and I believe they make a big difference, but there are still enough vaccines and not enough people to make that difference,” said the WHO Health Emergency. Michael Ryan, Executive Director of Situations, said in an online media briefing. Held jointly with Emory University on January 13th.
Ryan said, “Our weapon is our knowledge, weeks, if not months, ahead of us … we know about this virus, its transmission, and stopping it. That’s what I predicted.
“And hopefully we can end this horrific pandemic as vaccines come out.”
Schuitemaker reports a grant from BARDA during the investigation. Personal fees and other charges from the J & J company Janssen Vaccinesand Prevention, other than the submitted work. Johnson & Johnson and the Department of Health and Human Services’ Biomedical Advanced Research and Development Department funded Phase 1 / 2a research.
N Engl J Med.. Published online on January 13, 2021. Full text
Damian McNamara It is a staff A journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology and critical care. Follow Damian on Twitter: @MedReporter..