Vaccines
Coronavirus Vaccines
October 29, 2020 - These are the top coronavirus vaccines
Phase 3 Vaccines
Vaccines using nucleic acid (DNA and RNA)
Nucleic acid vaccines, developed by
Moderna; National Institutes of Health
Pfizer; BioNTech; Fosun Pharma
Vectored vaccines, developed by
AstraZeneca; University of Oxford
CanSino Biologics; Beijing Institute of Biotechnology; Canada's National Research Council; Petrovax
Gamaleya Research Institute*
Johnson & Johnson, Beth Israel Deaconess Medical Center
Subunit vaccines, developed by
AstraZeneca; University of Oxford
CanSino Biologics; Beijing Institute of Biotechnology; Canada's National Research Council; Petrovax
Gamaleya Research Institute*
Johnson & Johnson, Beth Israel Deaconess Medical Center
Institut Pasteur; Themis; University of Pittsburgh CVR; Merck Sharp & Dohme
Live attenuated or weakened virus vaccines, developed by
Beijing Institute of Biological Products; Sinopharm
Sinopharm
Sinovac
This coronavirus has a surface protein that is primed to lock on that receptor and slip its RNA into the cellTrial of Coronavirus Vaccine Made by Moderna Begins in Seattle
Moderna uses genetic material — messenger RNA
CureVac Bids to Develop First mRNA Coronavirus Vaccine
World Health Organization
March 4, 2020, COVID-19 candidate vaccines – 35 candidate vaccines
https://www.who.int/blueprint/priority-diseases/key-action/novel-coronavirus-landscape-ncov.pdf?ua=1
March 30, 2020 - Fact Sheet: Explaining Operation Warp Speed
Operation Warp Speed's goal is to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics (collectively known as countermeasures).
Select actions to support OWS vaccine and therapeutic development so far include:
March
March 30: HHS announced $456 million in funds for Johnson & Johnson's (Janssen) candidate vaccine. Phase 1 clinical trials began in Belgium on July 24th and in the U.S on July 27th. Janssen's large-scale Phase 3 clinical trial began on September 22, 2020, making them the fourth OWS candidate to enter Phase 3 clinical trials in the United States. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites in the United States and internationally.
April
April 16: HHS made
up to $483 million in support available for Moderna's candidate vaccine, which began Phase 1 trials on March 16 and received a fast-track designation from FDA. This agreement was expanded
on July 26 to include an additional $472 million to support late-stage clinical development, including the expanded Phase 3 study of the company's mRNA vaccine, which began on July 27th.
May
May 21: HHS announced up to $1.2 billion in support for AstraZeneca's candidate vaccine, developed in conjunction with the University of Oxford. The agreement is to make available at least 300 million doses of the vaccine for the United States, with the first doses delivered as early as October 2020, if the product successfully receives FDA EUA or licensure. AstraZeneca's large-scale Phase 3 clinical trial began on August 31, 2020.
July
July 7: HHS announced $450 million in funds to support the large-scale manufacturing of Regeneron's COVID-19 investigational anti-viral antibody treatment, REGN-COV2. This agreement is the first of a number of OWS awards to support potential therapeutics all the way through to manufacturing. As part of the manufacturing demonstration project, doses of the medicine will be packaged and ready to ship immediately if clinical trials are successful and FDA grants EUA or licensure.
July 7: HHS announced $1.6 billion in funds to support the large-scale manufacturing of Novavax's vaccine candidate. By funding Novavax's manufacturing effort, the federal government will own the 100 million doses expected to result from the demonstration project.
July 22: HHS announced up to $1.95 billion in funds to Pfizer for the large-scale manufacturing and nationwide distribution of 100 million doses of their vaccine candidate. The federal government will own the 100 million doses of vaccine initially produced as a result of this agreement, and Pfizer will deliver the doses in the United States if the product successfully receives FDA EUA or licensure, as outlined in FDA guidance, after completing demonstration of safety and efficacy in a large Phase 3 clinical trial, which began July 27th.
July 31: HHS announced approximately $2 billion in funds to support the advanced development, including clinical trials and large scale manufacturing, of Sanofi and GlaxoSmithKline's (GSK) investigational adjuvanted vaccine. By funding the manufacturing effort, the federal government will own the approximately 100 million doses expected to result from the demonstration project. The adjuvanted vaccine doses could be used in clinical trials or, if the FDA authorizes use, as outlined in agency guidance, the doses would be distributed as part of a COVID-19 vaccination campaign.
August
August 5: HHS announced approximately $1 billion in funds to support the large-scale manufacturing and delivery of Johnson & Johnson's (Janssen) investigational vaccine candidate. Under the terms of the agreement, the U.S. Government will own the resulting 100 million doses of vaccine, and will have the option to acquire more. The company's investigational vaccine relies on Janssen's recombinant adenovirus technology, AdVac, a technology used to develop and manufacture Janssen's Ebola vaccine with BARDA support; that vaccine received European Commission approval and was used in the Democratic Republic of the Congo (DRC) and Rwanda during the 2018-2020 Ebola outbreak that began in the DRC.
August 11: HHS announced up to $1.5 billion in funds to support the large-scale manufacturing and delivery of Moderna's investigational vaccine candidate. Under the terms of the agreement, the U.S. Government will own the resulting 100 million doses of vaccine, and will have the option to acquire more. The vaccine, called mRNA-1273, has been co-developed by Moderna and scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. NIAID has continued to support the vaccine's development including nonclinical studies and clinical trials. Additionally, BARDA has supported phase 2/3 clinical trials, vaccine manufacturing scale up and other development activities for this vaccine. The Phase 3 clinical trial, which began July 27, is the first government-funded Phase 3 clinical trial for a COVID-19 vaccine in the United States.
August 23: As part of the agency's efforts to combat COVID-19, the FDA issued an emergency use authorization (EUA) for investigational convalescent plasma. Based on available scientific evidence, the FDA determined convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in hospitalized patients, and that the known and potential benefits of the product outweigh the known and potential risks. The EUA authorizes the distribution of convalescent plasma in the U.S. as well as its administration by health care providers, as appropriate, to treat suspected or confirmed cases of COVID-19. Learn more about EUAs.
October
October 9: HHS announced an agreement with AstraZeneca for late-stage development and large-scale manufacturing of the company’s COVID-19 investigational product AZD7442, a cocktail of two monoclonal antibodies, that may help treat or prevent COVID-19. The goal of AstraZeneca’s partnership with the U.S. Government is to develop a monoclonal antibody cocktail that can help prevent infection. An effective monoclonal antibody that can prevent COVID-19, particularly one that is long-lasting and delivered by intramuscular injection, may be of particular use in certain groups. This includes people who have compromised immune function, those who are over 80 years old, and people undergoing medical treatments that preclude them from receiving a COVID-19 vaccine.
As announced on May 15, the vaccine development plan is as follows, subject to change as work proceeds:
- Fourteen promising candidates have been chosen from the 100+ vaccine candidates currently in development—some of them already in clinical trials with U.S. government support.
- The 14 vaccine candidates are being narrowed down to about seven candidates, representing the most promising candidates from a range of technology options (nucleic acid, viral vector, protein subunit), which will go through further testing in early-stage clinical trials.
- Large-scale randomized trials for the demonstration of safety and efficacy will proceed for the most promising candidates.
October 9, 2020 - Novavax: In The COVID-19 Vaccination Fast Lane
October 14, 2020 - Trump plans to transform America into manufacturing superpower
Trial of Coronavirus Vaccine Made by Moderna Begins in Seattle
Moderna uses genetic material — messenger RNA — to make vaccines, and the company has nine others in various stages of development, including several for viruses that cause respiratory illnesses. But no vaccine made with this technology has yet reached the market.
By Feb. 24, Moderna had a batch of vaccine ready to ship to the infectious diseases institute, for use in the trial. On March 4, the Food and Drug Administration gave permission for the trial to begin
CureVac Bids to Develop First mRNA Coronavirus Vaccine
RNA vaccine developer CureVac will receive a grant of up to €8.3M from a global partnership to develop an mRNA vaccine against the new coronavirus strain from China.
The agreement follows on from an existing collaboration launched in 2019, when the Coalition for Epidemic Preparedness Innovations, or CEPI, granted CureVac €30M to develop facilities that can ‘print’ mRNA vaccines. The aim of the new grant is to help CureVac’s preclinical-stage mRNA vaccine for the coronavirus strain to reach clinical trials as quickly as possible.
“Our aspiration is to bring the pathogen’s gene sequence to a vaccine candidate for clinical testing within a few months – which is significantly shorter than where we are now,” stated Richard Hatchett, the CEO of CEPI. “This is an extremely ambitious timeline and even if we are successful—and there can be no guarantee—there will be further challenges to navigate before we can make vaccines widely available.”
Inovio Pharmaceuticals begins human trials for COVID-19 vaccine
Each volunteer will receive two doses of the DNA-based vaccine four weeks apart, with immune response and side effect data expected by late summer or early fall.
While Inovio is using a relatively novel DNA-based approach to trigger an immune response to COVID-19, Moderna is tapping more established messenger RNA-technology with its vaccine to prevent coronavirus.
An approved vaccine probably won’t be available for a while, however. Experts predict it could take 12 to 18 months to get through the necessary safety and effectiveness testing to bring a vaccine to market. Inovio has 15 DNA-based medicines in development for a variety of diseases,
Depending on the results, Inovio plans a much larger Phase 2 trial with 1,000 or more participants —though the exact timing is unclear.
inovio pharmaceuticals-begins-trials-for-covid-19-dna-vaccine
Coronavirus Vaccine Could Be Ready in Six Months: Times
Researchers around the world are toiling to develop a vaccine for the coronavirus. But the creation of a working vaccine that can be safely distributed to a broad population requires a tremendous amount of rigor and caution, so the process is likely to take at least a year.
https://apple.news/AkJcj9VY-QouSaeao2UjISA
Here’s How Covid-19 Immunity Compares to Other Diseases. To stop the pandemic, it is critical to know how our immune system's antibodies fight the coronavirus
https://apple.news/AxPixTlD4SnqrHxfW_cIRMQ
Coronavirus Treatments and Vaccine Development
Vaccines
The race is most intense for a vaccine, a competition that thus far includes major drugmakers Johnson & Johnson, Pfizer and Moderna.
1) Johnson & Johnson
As one of the leading pharmaceutical companies working on a vaccine, Johnson & Johnson said Tuesday that it's aiming to produce between 600 million and 900 million doses of its own pending cure by the end of the first quarter of 2021 for emergency cases.
J&J also said it has committed more than $1 billion of investment in partnership with the federal Biomedical Advanced Research and Development Authority, which is part of the Department of Health and Human Services, to co-fund vaccine research.
Company executives said that if Phase I trials scheduled for September go according to plan it could wind up producing 1 billion or more doses annually. "We have very good early indicators that not only can we depend on this to be a safe vaccine base but also one that will ultimately be effective," J&J CEO Alex Gorsky told CNBC in March.
2) Moderna
Moderna was perhaps the first company to deliver the first experimental virus vaccine to U.S. government researchers when it shipped the maiden batch in February.
The company said in late February that it expected to start a clinical trial of about 20 to 25 healthy volunteers by the end of April in an attempt to see whether two doses of the remedy are safe and effective in developing immunity.
The U.S. government reinforced Moderna's research and development efforts with an additional $483 million in funding, which the company announced on Friday.
Moderna CEO Stephane Bancel said Friday on CNBC's "Squawk Box" that the funding is particularly critical in aiding manufacturing efforts. "Instead of waiting for the data and then scaling up with manufacturing process ... we can make as many doses as we can. We are doing both in parallel," he said. The company plans to hire up to 150 people to support the effort.
Chairman Noubar Afeyan told CNBC earlier in April that the drug had entered Phase I trials and hoped to advance to Phase II by late spring or early summer. Dr. Anthony Fauci, a central White House health advisor and director of the National Institute of Allergy and Infectious Diseases, said Moderna's Phase I trial was launched at "record speed."
3) Pfizer
New York-based Pfizer is also working on a vaccine, which the drugmaker hopes to begin testing in patients in summer 2020. Chief Scientific Officer Mikael Dolsten said earlier in April that the vaccine candidate works by restricting the virus's ability to replicate or expand.
Pfizer had initially planned to begin clinical trials for its Covid-19 candidate by the end of the year, but it's moved up that timeline to start in the third quarter.
On top of that effort, Pfizer is working with BioNTech SE of Germany to generate a vaccine based on cutting-edge gene-based technology. Pfizer expects trials for that vaccine to commence as early as the end of April.
Though the monthslong hunt for a viable, effective drug candidate may appear slow to those unfamiliar with the health-care industry, Jefferies health-care strategist Jared Holz cautioned that the current forecasts represent breakneck speed.
"Typically, vaccines from start to finish may take as long as ten years to complete; here we have been talking about two years or less," he wrote in an email. "The primary factor(s) aiding optimistic thinking are government authorities (including the FDA) intent to fast track the process in order to salvage the country/world from this epidemic."
"Moderna, Johnson & Johnson and Pfizer seem to be in the lead, so to speak," he added. "In this scenario, given how dire, the first to market advantage could be pretty significant."
4) Others
Rockville, Maryland-based Novavax's vaccine candidate, dubbed NVX-CoV2373, neutralizes a protein "spike" that virus can induce in patients. The company said on April 8 that the vaccine candidate showed a robust immune response in the animals that it tested and that its phase 1 trial in about 130 adult humans should begin mid-May.
Inovio Pharmaceuticals, meanwhile, said on April 6 that the Food and Drug Administration had accepted its vaccine candidate, INO-4800, setting the stage for phase 1 human trials. The company added that the phase 1 study will enroll up to 40 healthy adult volunteers in Philadelphia and that each participant will receive two doses of INO-4800 four weeks apart. Initial immune responses and safety data from the study are expected by late summer.
June 25 - 254 Treatments and 172 Vaccines
Explore detailed information on each development: