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COVID 2020 - Policy, vaccines, therapies, and testing
è stata creata
MedicalGold.ca
⟶ è stato aggiornato 16 set 2021 ⟶
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16 set 2021
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COVID 2021 - Policy, vaccines, therapies, and testing
16 set 2021
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COVID 2021 - Government
Commenti
Eventi
The US enters into a $1.5B deal with Moderna for 100 million doses of mRNA-1273, their lead candidate vaccine, to be priced at $15 per dose. The Phase III trial is still underway.
Biden calls for a 3-month mask mandate. Southern states are quick to rebuke.
The FDA approves another saliva test developed at Yale School of Public Health.
The FDA clears convalescent plasm for use. This plasma is harvested from recovered COVID-19 patients, and contains antibodies ready to fight off infection.
The FDA approves Abbott’s rapid nasal swab test.
The US decides it will not participate in the WHO’s initiative to develop and distribute the COVAX vaccine, a global access vaccine guaranteed for rapid and equitable access to more than 150 countries.
• AstraZeneca halts their Phase III vaccine trial due to safety reasons. • The Pfizer-BioNTech partnership expand their Phase III trial by 50% to increase data on safety and efficacy in a more diverse population. Vaccine is administered in 2 shots, 3 weeks apart. Storage conditions are a challenge.
Trump announces a vaccine distribution plan that will roll out in January 2021, but does not include information on who will receive the vaccine first.
Johnson and Johnson begins their Phase III trial. Its 60,000 participants make it the largest Phase III trial underway.
A new variant of the virus is discovered. Researchers note that this new strain contains mutations that make the virus more infectious.
The HHS plans to distribute 100 million Abbott rapid tests across the country by end of 2020. These tests are cheap and can deliver results in 15 minutes.
Regeneron’s monoclonal antibody treatment shows positive results in a Phase I/II/III trial. The cocktail is a mixture of 2 monoclonal antibodies: REGN10933 and REGN10987).
Trump and the First Lady test positive for COVID-19. Trump is hospitalized, but discharged after only 3 days.
Trump’s treatment consisted of Regeneron’s investigational antibody cocktail, remdesivir, and dexamethasone.
The US executes a $500M deal with AstraZeneca to develop an antibody treatment for COVID-10.
Johnson and Johnson halt their large Phase III vaccine trial over safety concerns. The company resumes the trial with a single dose.
The FDA approves remdesivir as the first fully approved COVID-19 treatment, citing a decrease in length of hospital stays and a reduction in the probability of ventilation. This decision flies in the face of the WHO’s position on the drug.
AstraZeneca and Johnson and Johnson restart their vaccine trials after an independent monitoring committee declares them safe to continue.
President-elect Joe Biden appoints a new COVID-19 advisory board, in anticipation of his win.
Pfizer announces their vaccine is 90% effective.
The FDA grants an EUA for Eli Lilly’s monoclonal antibody treatment, bamlanivimab. Lilly showed that hospitalizations in COVID-19 patients decreased within 28 days, indicating that it prevents severe forms of the disease when administered quickly.
Moderna publishes clinical trial results showing 94.5% efficacy for their mRNA vaccine. FDA promises to move quickly in granting EUAs to Pfizer and Moderna while the companies continue with their Phase III trials. Pfizer announces 95% efficacy for their mRNA vaccine.
AstraZeneca announces 90% efficacy for their vaccine when administered at a half dose followed by a full dose 1 month later.
FDA advisory panel endorses the Pfizer-BioNTech vaccine, and FDA grants EUA.
The FDA advisory panel endorses Moderna vaccine and grants EUA.
Novavax commences Phase III trial for their vaccine, NVX-CoV2373, in a 30,000 patient study conducted in Mexico.
The WHO declares COVID-19 as a global pandemic.
Trump declares COVID-19 a national emergency and travel bans to Europe go into effect.
The WHO recognized an outbreak of coronavirus-related pneumonia in Wuhan, China.
The CDC confirmed the first US case of coronavirus.
Wuhan is quarantined and the WHO declares a global health emergency.
The US declares a public health emergency.
The US Senate passes the CARES ACT, which is signed into law on March 27, 2020.
The FDA authorizes the use of hydroxychloroquine via Emergency Use Authorization to treat COVID-19 patients, but trials halt in June as the “Solidarity Trial” fails to demonstrate efficacy of the drug.
A NIH trial for remdesivir as a treatment for COVID-19 gains traction, and wins an EUA.
The US strikes a deal with AstraZeneca for their AZD1222 vaccine to speed up development. AstraZeneca committed to producing at least 300 million doses. Note: AstraZeneca holds a major stake in Moderna Therapeutics, a competing vaccine developer.
Gilead, the manufacturer of remdesivir (paid for by taxpayer dollars), outrages the public with a $3,120 per dose price tag on the only viable treatment for COVID-19 at the time.
Trump decides to withdraw from the WHO due to their poor handling of the pandemic.
Moderna’s Phase I/II trial shows positive data.
AstraZeneca’s Phase I/II clinical trial for AZD1222 demonstrated a robust immune response (neutralizing antibody levels).
Moderna begins their Phase III vaccine trial and receives almost $500M from the government. BARDA has invested a total of almost $1B in Moderna’s research.
The FDA grants Truvian the first EUA for a rapid antibody test. The company reported a sensitivity rate of 98.44% (very low % of false negatives) and a specificity rate of 98.9% (very low % of false positive).
The US enters into a $2B deal with GlaxoSmithKline and Sanofi Pasteur to develop and scale up delivery of the partnership’s vaccine.
The first saliva-based test is allowed for in-home use (Rutgers Clinical Genomics Laboratory).
