The race is on to find a COVID-19 vaccine or treatment. As a result, there are many clinical trials taking place around the world. At the same time, COVID-19 is also impacting ongoing clinical trials for other serious illnesses.
This news digest includes the latest on clinical trials, both advancements to speed up COVID-19 trials and impacts of the pandemic on ongoing clinical trials.
- Pfizer and BioNTech achieve first authorization in the world for a vaccine to combat COVID-19. UK Medicines & Healthcare Products Regulatory Agency (MHRA) has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. Read the news.
- EMA publishes safety monitoring plan and guidance on risk management for COVID-19 vaccines. The plan is to ensure that all new information collected post-marketing will be promptly reviewed and any emerging new information will be shared with the public in a timely manner. Read more.
- Pfizer and BioNTech conclude Phase III study of COVID-19 vaccine candidate, meeting all primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Read more.
- Moderna COVID-19 vaccine candidate meets primary efficacy endpoint. The Phase III study of mRNA-1273 met the statistical criteria pre-specified in the study protocol, with a vaccine efficacy of 94.5%. Read more.
- FDA authorizes monoclonal antibody for treatment of COVID-19. The FDA issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. The EUA was issued to Eli Lilly. Read the details.
- Novavax COVID-19 vaccine granted fast track designation by FDA. Novavax announced that the FDA has granted Fast Track Designation for NVX-CoV2373, the company’s COVID-19 vaccine candidate. The company expects to begin its pivotal Phase III clinical trial in the United States and Mexico by the end of November. Read more.
- EMA implements extra transparency measures for COVID-19 vaccines and therapeutics. The European Medicines Agency (EMA) has published clinical data in support of the authorization of Veklury (remdesivir) and information on COVID-19 treatments and vaccines that have received scientific advice or informal guidance from its pandemic task force. Read the article.
- FDA approves first treatment for COVID-19. The US FDA approved antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years and older and weighing at least 40 kilograms for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Read the article.
- Eli Lilly pauses trial of antibody drug over safety concern. The ACTIV-3 clinical trial is paused because of a safety concern. Read the article.
- J&J pauses coronavirus vaccine trials due to unexplained illness. Johnson & Johnson said the illness was being reviewed by an independent data and safety monitoring board as well as the U.S. group’s clinical and safety physicians. Read the article.
- EMA starts second rolling review, this time for Pfizer COVID-19 vaccine. The European Medicines Agency's human medicines committee (CHMP) has started a "rolling review" of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. Read the details.
- FDA publishes vaccine rules. The FDA released new safety standard for COVID-19 vaccines, with guidance that vaccine makers should follow clinical trial participants for at least two months to rule out safety issues before seeking emergency use authorization for a vaccine. Read the article.
- FDA reshuffles priorities to meet COVID-19 trial demand. The sudden influx of COVID-19 trials work at the FDA has required pulling resources from various departments at the agency to support the efforts. Read the article.
- Eli Lilly rushes to FDA with its COVID-19 antibody for emergency green light, reveals new cocktail therapy data. Lilly submitted an initial request for emergency use authorization for its antibody treatment, specifically for higher-risk patients who have been recently diagnosed with mild to moderate COVID-19. Read the article.
- GSK and Vir to expand COVID-19 antibody treatment study. GSK and Vir Biotechnology are set to globally expand the study of experimental antibody VIR-7831 for the early treatment of COVID-19 patients with a high risk of hospitalization to Phase III. Read the article.
- How research nurses and midwives are supporting COVID-19 clinical trials in the UK. Clinical research nurses and midwives have been central to the rapid implementation of COVID-19 clinical trials. Read the article.
- EMA begins real-time review of AstraZeneca’s COVID-19 vaccine. The European Medicines Agency initiated the first "rolling review" of a COVID-19 vaccine developed by AstraZeneca and the University of Oxford. Read the article.
- Pfizer follows Moderna in releasing COVID-19 vaccine study protocol. Protocols are typically kept under wraps until studies are complete, but Pfizer and Moderna have made their SARS-CoV-2 trial protocols public in a transparency push. Read the article.
- First patient in OSCAR trial receives GSK’s otilimab in UK. The Manchester University NHS Foundation Trust in the UK has said that the first patient in the OSCAR clinical trial received GSK’s investigational drug otilimab to treat severe lung disease related to COVID-19. Read the article.
- Johnson & Johnson’s single-dose COVID-19 vaccine generates strong immune response, early data shows. The company released positive interim results of its Phase I/IIa study. It has moved into a Phase III trial that will enroll up to 60,000 volunteers across three continents. Read the article.
- Older people likely to be underrepresented in COVID-19 trials. A study published in JAMA Internal Medicine concludes that despite the fact that people over 65 are disproportionately impacted by COVID-19, they are underrepresented in the clinical trials. Read the article.
- Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance. Investigators should review and report AEs and SAEs, according to updated FDA guidance. Read the full article.
- Pfizer and BioNTech propose expansion of pivotal COVID-19 vaccine trial. The companies have submitted an amended protocol to expand the enrollment of their Phase III pivotal COVID-19 vaccine trial to up to 44,000 participants. Read more.
- UK’s MHRA allows restart of Oxford/AstraZeneca COVID-19 vaccine trials. The Medicines Health Regulatory Authority (MHRA) in the UK has said that the clinical trials of the Oxford/AstraZeneca COVID-19 vaccine candidate are safe to resume. The late-stage trials were paused after a participant in the UK study experienced an unexplained illness. Read the full article.
- Biopharma leaders unite to stand with science. Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines. Read the pledge.
- Sanofi and GSK move COVID-19 vaccine into human trials. Sanofi and GSK are launching a large Phase I/II clinical trial at 11 sites across the US, initially enrolling 400 people. This candidate is the first outside of China to use a vaccine approach for which there is already a licensed vaccine. Read the full article.
- Sanofi says Kevzara drug fails as possible COVID-19 treatment. The international Phase III clinical trials of Kevzara didn't meet primary or secondary endpoints and as a result trials will be stopped. Read the full article.
- Phase III clinical testing of AstraZeneca COVID-19 vaccine candidate begins. A multi-site, Phase III clinical trial for AZD1222 has begun. The trial will enroll 30,000 adult volunteers at 80 sites in the US. Read more.
- Translate Bio, Sanofi COVID-19 vaccine proves promising in animal studies. Experimental COVID-19 vaccine induced immune responses in animal studies. The companies plan to start human trials in November. Read the full article.
- COVID-19 and readjusting clinical trials. The disruptions from the pandemic are numerous, but there are some reasons to be optimistic about changes with clinical trials, according to the Lancet. Read the full article.
- COVID-19 clinical trials must append more diversity, researchers assert. Researchers raise concerns about the lack of diversity in COVID-19 clinical trials. Read the full article.
- Disruptions to global oncology trials have fallen to a three-month low. Cancer trials disrupted by COVID-19 are resuming faster than other therapeutic areas. Read the full analysis.
- FDA Coronavirus Treatment Acceleration Program (CTAP) dashboard. This dashboard provides updates specifically on therapeutics (not vaccines or devices). View dashboard.
- Many early COVID-19 studies have low-quality design, risk low-value evidence, research finds. The researchers estimated that only about 29% of studies would produce data strong enough to potentially inform changes in clinical care. Read the full article.
- US biotech uses AI to pick antiviral for COVID-19 trial. US biotech AI Therapeutics begins a Phase II trial of its LAM-002A, an antiviral drug. The company develops drugs identified with a proprietary artificial intelligence (AI) algorithm. Read the full article.
- "Promising" data on Oxford/AZ coronavirus vaccines. Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus. Read the full article.
- Moderna COVID-19 vaccine candidate has positive results in all participants in Phase I trial. Moderna published interim analysis of the open-label Phase 1 study of mRNA-1273 in the New England Journal of Medicine. A Phase III trial is expected to start later in July. Read the report.
- NIH launches trials network for COVID-19 vaccines and therapies. The COVID-19 Prevention Trials Network (COVPN) is expected to operate more than 100 trial sites across the US and internationally. The first Phase III trial conducted is expected to be Moderna’s mRNA-1273 vaccine. Read the full article.
- UK universities launch new COVID-19 drug testing platform. The University of Liverpool School of Tropical Medicine and Southampton Clinical Trials Unit launched a COVID-19 drug testing platform called AGILE. It will test multiple potential therapeutics. Read the full article.
- UK trial begins testing second-wave COVID-19 drug from US biotech Ridgeback. Ridgeback Biotherapeutics is starting enrollment for a Phase II trial for its oral antiviral drug EIDD-2801, which will be conducted using the AGILE testing platform. Read the full article.
- Running clinical trials for other drugs in the age of COVID-19. There is some evidence of recovery for clinical trials beyond COVID-19. Read the full article.
- Some COVID-19 trial sponsors never posted other study results in an EU database. Will they hide data again? Two-thirds of 118 COVID-19 clinical trials analyzed by the non-profit research advocacy group TranspariMED had no record of uploaded results to the European Union Drug Regulating Authorities Clinical Trials Database, though it is required under EU rules. Read the full article.
- MHRA instructs all UK hydroxychloroquine COVID-19 clinical trials to suspend recruitment. UK clinical trials using hydroxychloroquine to treat or prevent COVID-19 should stop recruiting further participants, Medicines and Healthcare products Regulatory Agency (MHRA). Read the full article.
- COVID-19 vaccine development pipeline gears up. There are 10 COVID-19 vaccines in clinical trials. They are working at a rate that could defy usual timetables, which on average is 10 years to develop a new vaccine. Read the full article.
- FDA’s MyStudies app provides platform for electronic informed consent. The U.S. Food and Drug Administration is making its FDA MyStudies app available to investigators for free to obtain informed consent from patients when face-to-face contact is not possible or practical due to COVID-19. Read the full article.
- How COVID-19 could improve clinical trial conduct. Sheuli Porkess Director, Research, Medical and Innovation from the Association of the British Pharmaceutical Industry talks about three areas for change with clinical trials. Read the full article.
- The COVID-19 pandemic and clinical trial disruptions. Nearly 70% of global clinical trials have been disrupted by enrollment suspensions, according to research. Read the full article.
- FDA updates COVID-19 clinical trials guidance to address serious adverse events. The FDA updated guidance for clinical trial conduct, including how and when serious adverse events should be reported. Read the full article.
- Institute for Advanced Clinical Trials for Children launches program to speed up COVID-19 pediatric trials. The Institute for Advanced Clinical Trials for Children (I-ACT for Children) launched the COVID-19 Emergency Access Program to speed up the development of pediatric COVID-19 trials. Read the full article.
- Clinical trials press on for conditions other than COVID-19. Will the pandemic’s effects sneak into their data? Researchers will need to adjust their studies during the pandemic. Disruptions to movement and visit schedules and/or sickness or death caused by COVID-19 could impact the data of ongoing clinical trials. Read the full article.