The lightning-fast quest for COVID vaccines — and what it means for other diseases (December 18) – The COVID-19 experience will almost certainly change the future of vaccine science.
Moderna Announces FDA Authorization of Moderna COVID-19 Vaccine in U.S. (December 18)
F.D.A. Panel Endorses Moderna’s Covid-19 Vaccine (December 17) – An advisory group’s recommendation will mean millions more Americans can be inoculated, extending protection against Covid beyond major urban areas into rural and suburban regions.
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine (December 10) – The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Safety over a median of 2 months was similar to that of other viral vaccines.
F.D.A. Advisory Panel Gives Green Light to Pfizer Vaccine (December 10)
Tracking today’s FDA advisory panel meeting on the Pfizer/BioNTech Covid-19 vaccine (December 10).
FDA Staff Find Few Faults with Pfizer-BioNTech COVID-19 Vax (December 8) – The Pfizer-BioNTech mRNA COVID-19 vaccine candidate (BNT162b2) appeared to meet criteria for an emergency use authorization, with no major concerns raised by FDA staff in a briefing document released by the agency Tuesday. –
Oxford COVID vaccine paper highlights lingering unknowns about results (December 8) – The Oxford–AstraZeneca partnership is the first major developer to publish detailed data from phase III trials.
Former FDA chief Rob Califf on the vaccine approval process (December 4) – This interview focuses on the EUA process, the science, and who should make the final call, this as the FDA is reviewing two emergency use authorization requests for COVID-19 vaccines.
UK authorises Pfizer/BioNTech COVID-19 vaccine (December 2) – The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.
Moderna to file for FDA emergency use authorization for COVID-19 vaccine (November 30) – Moderna will become the second company to file for a vaccine EUA after Pfizer did the same earlier this month, potentially paving the way for the U.S. to have two COVID-19 vaccines in distribution by the end of the year. The company said its vaccine has a 100% efficacy rate against severe COVID cases.
Oxford professor Sir John Bell discusses the timeline of the AstraZeneca Covid vaccine (November 27) – Professor Sir John Bell, Oxford University, and Andrew Lloyd Webber, legendary theater composer, join ‘Closing Bell’ to discuss the AstraZeneca vaccine trial that’s currently ongoing.
The AstraZeneca Covid Vaccine Data Isn’t Up to Snuff (November 25) – The initial promising results have been labeled concerned by skeptics, stating more data is required before coming to a conclusion. The main reason being that the results presented were not from a single, large-scale, Phase 3 clinical trial, as was the case for earlier bulletins about the BNT-Pfizer and Moderna vaccines. Instead, Oxford-AstraZeneca’s data came out of two separate and substantially different studies: they didn’t have standardized dosing schemes across the trials, for one thing, nor did they provide the same “control” injections to volunteers who were not getting the experimental Covid vaccine. The fact that they may have had to combine data from two trials in order to get a strong enough result raises a red flag.
AstraZeneca’s Coronavirus Vaccine, Easy and Cheap to Produce, Appears Effective (November 23) – An early analysis of data from late-stage clinical trials found that AstraZeneca’s vaccine was either 62 percent or 90 percent effective, depending on the manner in which the doses were given.
Vaccitech Co-Founder Professor Adrian Hill on Developing a Covid-19 Vaccine (November 25) – GV talks to Adrian Hill about the highly effective COVID-19 vaccine developed by AstraZeneca, the University of Oxford, and the GV portfolio company Vaccitech. Adrian Hill recounts the story behind his search for a vaccine, results from late-stage clinical trials, the challenges of manufacturing and global distribution — and what has to happen next to stop the virus.
Pfizer Applies for Emergency F.D.A. Approval for Covid-19 Vaccine (November 22) – This will set in motion an accelerated regulatory process that could allow the first Americans to get a vaccine by the middle of December.
Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study (November 16) – Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001) with the first interim analysis including 95 participants with confirmed cases of COVID-19.
The Husband-and-Wife Team Behind the Leading Vaccine to Solve Covid-19 (November 10) – Some details about the husband and wife team Uğur Şahin and Özlem Türeci, the couple that founded the German company BioNTech, and how they teamed up with Pfizer on a vaccine that was found to be more than 90 percent effective.
Covid-19 vaccine candidate is 90% effective, says manufacturer (November 9) – The first interim results in large-scale trials of COVID-19 vaccine shows that the Pfizer/BioNTech candidate is 90% effective.
Moderna’s coronavirus vaccine trial is fully enrolled, 37 percent of participants are minorities (October 23) – Moderna anticipates that it may have sufficient data to seek a regulatory OK for its vaccine in mid-November – has now enrolled all 30K participants in clinical trial.
Putin Announces Approval Of A 2nd Unproven Coronavirus Vaccine (October 14) – EpiVacCorona, a “peptide-based shot,” has not yet completed the kind of extensive and rigorous three-phase trials required in the U.S.
CDC optimistic coronavirus vaccines will be released by end of the year (October 15) – The US Centers for Disease Control and Prevention posted an optimistic forecast about coronavirus vaccines Wednesday, promising some vaccines by the end of the year.
Biotech Industry Pushes Trump Administration to Release New Vaccine Guidelines (October 5) – Stricter criteria for the emergency authorization of any coronavirus vaccine is causing growing angst within the biotech industry. The new guidelines, which have been drafted by experts at the Food and Drug Administration and are subject to White House approval, would set forth specific criteria for clinical trial and safety data, add another layer of caution to the vaccine vetting process. The F.D.A. appeared poised to release them last week, but the process seems stalled since Mr. Trump said last Wednesday that the White House “may or may not” approve the new stricter criteria.
Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial (September 17) – Moderna released a 135-page document spells out the details of how it is conducting the late-stage trial of its coronavirus vaccine, and how safety and efficacy will be determined. The document suggests that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Subsequent analyses, scheduled for March and May, are more likely to provide an answer.
Drugmaker Pauses Covid-19 Vaccine Trial for Safety Review (September 8) – AstraZeneca halts a vaccine trial to investigate a participant’s illness. A volunteer in the U.K. trial had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.
Let’s get real. No vaccine will work as if by magic, returning us to ‘normal’ (September 6) – The “first” vaccine, or even the first generation of vaccines, will most likely not be perfect; we need to be pragmatic and transparent on that front. The first generation of Covid19 vaccines will probably be only partially effective. They might not be completely effective in all ages or appropriate in all health systems. It is very possible that they might provide immunity only for a limited period, even as short as 12 to 18 months. This might not be what we are used to from a vaccine, but there is no doubt that the first effective vaccines, even imperfect ones, can have a major impact and be a precious commodity.
#COVID19 #SARSCoV2 #coronarvirus
Twist Bioscience Announces Potent SARS-CoV-2 Neutralizing Data from COVID-19 Therapeutic Antibody Program (September 2) – Data demonstrating the potent neutralizing effects of multiple potential therapeutic antibodies, both Immunoglobulin G (IgG) antibodies and substantially smaller single domain VHH “nanobodies,” against SARS-CoV-2.
Liability risks emerge as an obstacle in Europe’s COVID-19 vaccine negotiations (August 26) – With all eyes on the hunt for #COVID19 vaccines, Europe’s supply negotiations with drugmakers have hit snags over potential liability for side effects. So far only AstraZeneca has completed an agreement—for 400 million doses.
In the race for a Covid-19 vaccine, Pfizer turns to a scientist with a history of defying skeptics — and getting results (August 24) – The company’s head of vaccine research and development, Jansen, 62, has led the development of the world’s two best-selling vaccines, against human papilloma virus and pneumococcus, at two different companies.
Moderna Wants to Transform the Body Into a Vaccine-Making Machine (August) – The U.S. company and its German rival BioNTech plan to use RNA as a messenger inside cells to produce an immune reaction. The advance could upend vaccine development long after the pandemic.
Coronavirus Vaccine Tracker (August 14) – Allows to see the status of all the vaccines currently developed around the world – more than 165 vaccines against the coronavirus, with 31 vaccines in human trials. Vaccines typically require years of research and testing before reaching the clinic, but scientists are racing to produce a safe and effective vaccine by next year. A NYT tools.
Designer antibodies could battle COVID-19 before vaccines arrive (August 4) – Designer antibodies have the potential to be an important bridge until a vaccine is available.
Moderna Launches Phase III COVID-19 Vaccine Trial with $472 Million More in BARDA Funding (July 27) – Moderna Launches Phase III COVID-19 Vaccine Trial with $472 Million More in BARDA Funding.
Moderna coronavirus vaccine shows ‘promising’ safety and immune response results in published Phase 1 study, but more research is needed (July 15) – The Phase I trial was also evaluating the safety of the vaccine. The side effects were generally mild to moderate, including fatigue, chills, headache, muscle pain, and pain at the injection site. The authors of the study indicated there were “no trial-limiting safety concerns.” The more moderate side effects were typically observed in the higher dose of the vaccine, and typically more after the second dose. In the study, about 80% described fatigue at the second 100-microgram dose, 60% reported headache, and 53% described muscle pain. They all went away in a day or two.
Covid Vaccine Front-Runner Is Months Ahead of Her Competition (July 14) – The University of Oxford candidate, led by Sarah Gilbert, might be through human trials in September. AstraZeneca has lined up agreements to produce 2 billion doses. Could this be the one?
Elegant but unproven, RNA experiments leap to the front in coronavirus vaccine race. Will they work? (July 5) – Scientists are pushing to develop, and possibly manufacture, vaccines in a completely new way. This promising — but unproven — new generation of vaccine technologies is based on deploying a tiny snip of genetic code called messenger RNA to trigger the immune system. It has never before been approved for use.
A Covid-19 Vaccine Shows Encouraging Signs (July 1) – Developed by Pfizer and BioNTech, an experimental vaccine spurred immune responses in a small trial of humans.
WHO, partners unveil ambitious plan to deliver 2 billion doses of Covid-19 vaccine to high-risk populations (June 26) – The World Health Organization and key partners unveiled a plan Friday to purchase 2 billion doses of Covid-19 vaccines for the highest risk populations of the world. The plan anticipates that by the end of 2021, the doses could be delivered to countries to vaccinate high risk individuals, likely including health care workers, people over the age of 65, and other adults who suffer from conditions like diabetes. The cost is estimated at $18.1B to deliver on the plan. The effort is one pillar of the WHO’s effort to ensure all countries have access to Covid-19 vaccines, therapeutics, and diagnostics, called the ACT Accelerator, short for Access to Covid-19 Tools.
Finding Antibodies that Neutralize SARS-CoV-2 (June 18) – The good news is that when researchers looked at individuals who mounted a strong immune response, they were able to identify three antibodies that were extremely effective at neutralizing SARS-CoV-2. By mass-producing copies of these antibodies as so-called monoclonal antibodies, the researchers can now better evaluate their potential as treatments to help people who don’t make strongly neutralizing antibodies, or not enough of them.
Emergent BioSolutions, BARDA reach $628M deal to manufacture COVID-19 vaccine hopefuls (June 1) – The contract is part of the government’s “Operation Warp Speed” development initiative to speed promising COVID-19 vaccines through clinical trials and into mass production before the end of 2020.
Merck to Acquire Austrian Vaccine Maker Themis Bioscience to enter COVID-19 race (May 26) – Themis has a broad pipeline of vaccine candidates and immune-modulatory therapies developed using its innovative measles virus vector platform based on a vector originally developed by scientists at the Institut Pasteur and licensed exclusively to Themis for select viral indications. In March, Themis joined a consortium together with the Institut Pasteur and The Center for Vaccine Research at the University of Pittsburgh, supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to develop a vaccine candidate targeting SARS-CoV-2 for the prevention of COVID-19.
AstraZeneca advances response to global COVID-19 challenge as it receives first commitments for Oxford’s potential new vaccine (May 21) – First agreements to supply at least 400 million doses; Company has total capacity sourced for one billion doses through 2020 and into 2021; continues to increase capacity further. More than $1bn US BARDA investment to support development and production of the vaccine
Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine (May 19) – While Moderna blitzed the media, it revealed very little information — and most of what it did disclose was not a lot of data. The company’s statement led with the fact that all 45 subjects (in this analysis) who received doses of 25 micrograms (two doses each), 100 micrograms (two doses each), or a 250 micrograms (one dose) developed binding antibodies. It was that eight volunteers — four each from the 25-microgram and 100-microgram arms — developed neutralizing antibodies. We don’t know results from the other 37 trial participants. This doesn’t mean that they didn’t develop neutralizing antibodies. Moderna disclosed the findings from eight subjects because that’s all it had at that point.
Google sister-company Verily is launching an antibody research study for Covid-19 (May 18) – Verily is adapting its existing clinical trial technology, Project Baseline, to the coronavirus. Its initial focus will be to study antibody testing. There are still many unknowns when it comes to antibody tests. And there’s a wide variation in the accuracy of the tests.
Coronavirus Vaccine Trial by Moderna Shows Promising Early Results (May 18) – The company said its preliminary test in 8 healthy volunteers was safe. It is on an accelerated timetable to begin a larger human trial soon.
Investigational ChAdOx1 nCoV-19 vaccine protects monkeys against COVID-19 pneumonia (May 13) – Based on these data, a Phase 1 trial of the candidate vaccine began on April 23 in healthy volunteers in the United Kingdom.
Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus (May 12)
Gene Vaccine (May 5) – Progress towards the testing and development of an experimental vaccine called AAVCOVID—a novel gene-based vaccine candidate against SARS-CoV-2, the virus that causes COVID-19 is described within this article.
How Long Will a Vaccine Really Take? (April 30) – Great overview with interactive infographic on how long it takes to develop a vaccine, and why even 18 months for a vaccine against COVID is a dramatic acceleration.
The race for coronavirus vaccines: a graphical guide (April 28) – More than 90 vaccines are being developed against SARS-CoV-2 by research teams in companies and universities across the world. Researchers are trialling different technologies, some of which haven’t been used in a licensed vaccine before.
Sanofi is preparing to manufacture 100 million doses of COVID-19 vaccines (April 24) – There are 76 vaccine candidates for COVID-19, five of which are in clinical trials. It will take at least 18 months to determine if these vaccines are effective and safe enough to distribute en masse. Then, distributing them to millions of people will require an incredible feat of manufacturing. To address this problem, the company is looking at how it can use existing manufacturing space to ramp up COVID-19 vaccines.
Single-Dose Adenovirus-Based COVID-19 Vaccine Planned (April 24) – Three European biotech companies agreed to collaborate on the development and large-scale manufacture of a novel adenoviral vector-based vaccine against COVID-19. The vaccine candidate is expected to enter clinical trials during summer 2020 with large-scale vaccine production planned to start soon after.
Coronavirus: UK scientists start mass producing vaccines while trials are still under way (April 18) – Oxford University researchers say the world can’t afford to wait for vaccines to go through trials before production starts.
Manufacturing Platform Developed for Large-Scale Production of COVID-19 Vaccine Candidate (April 14) – MilliporeSigma and The Jenner Institute report that the Institute has begun preparations for the large-scale production of its COVID-19 vaccine candidate, ChAdOx1 nCoV-19.
Sanofi Expands COVID-19 Pipeline with Translate Bio Partnership (March 27) – The COVID-19 collaboration—whose value was not disclosed—is intended to combine vaccine expertise and external research networks of Sanofi Pasteur, Sanofi’s vaccines global business unit, with Translate Bio’s mRNA platform, which the companies will apply to discover, design, and manufacture SARS-CoV-2 vaccine candidates.
First Results From Moderna Covid-19 Vaccine May Take Two More Months (March 25) – Moderna announced dosing the first patient in the early stage study of mRNA-1273 on March 16. The trial in 45 healthy people is being run by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, with patients in the study getting two doses of the vaccination 28 days apart. While NIH has control over when results will be disclosed, management guided to data availability in the near-term and suggested that the first data release will likely include a full cohort (>3-5 patients) to reflect the totality of the scientific picture.
Mount Sinai to Begin the Transfer of COVID-19 Antibodies into Critically Ill Patients (March 24) – The Mount Sinai Health System plans to initiate a procedure known as plasmapheresis, where the antibodies from patients who have recovered from COVID-19 will be transferred into critically ill patients with the disease, with the expectation that the antibodies will neutralize it. The process of using antibody-rich plasma from COVID-19 patients to help others was used successfully in China, according to a state-owned organization, which reported that some patients improved within 24 hours, with reduced inflammation and viral loads, and better oxygen levels in the blood.
As the First Coronavirus Vaccine Human Trials Begin, Manufacturer Is Already Preparing to Scale Production to Millions (March 23) – The vaccine will be studied first in a group of 45 healthy volunteers, who have not been infected with SARS-CoV-2, the virus that causes COVID-19. In this group, scientists are looking to see if the shots are safe, and to test three different dosages to see which seems to activate the strongest immune response. Moderna uses mRNA, a genetic form of the virus’ genome, in its vaccine. When it’s injected into people, cells then process it so immune cells can recognize it and target it for destruction. Unlike the processes used to make most traditional vaccines, this method does not require growing huge amounts of the virus, which is time-consuming.
Everything You Need to Know About Coronavirus Vaccines (March 4) – As Covid-19 spreads, the pressure is on for drugmakers to get a vaccine to market. But it’s not that easy. Includes a list of companies working on a vaccine with a breakdown of the 30+ candidates in development (so far).
