USA biotech firm Moderna reported "positive interim" results on Monday in the first clinical tests of its vaccine against the new coronavirus performed on a small number of volunteers. The alternative is simply to give test subjects doses of the vaccine and see who ends up COVID-positive in the normal course of their lives - a process which is less controversial but requires much more time.
The 15 volunteers at the weakest dose strength also had antibodies in their blood at similar levels to people who recovered from COVID-19, after receiving both doses.
The vaccine, mRNA-1273, was also found to be generally safe and well tolerated in the early-stage study, the drug developer said.
The early readout included arms of the trial involving people ages 18 to 55 years old who received either two doses at the 25 microgram or 100 microgram level or one dose at 250 microgram.
The NIH's National Institute of Allergy and Infectious Diseases (NIAID) is leading the Phase II trial (NCT04283461) of mRNA-1273, a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein.
He said it makes sense to Moderna to move into Phase 3 without vaccinating that many people, given that Covid-19 is killing thousands of people each day.
In a conference call, Moderna CEO Stephane Bancel said the preliminary tests inspired confidence that mRNA-1273 has "a high probability to provide protection" against the virus.
The biggest risk forward, he said, is not having enough cases to demonstrate the vaccine candidate works in phase three.
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Those individuals were ordered into quarantine but the school has remained open, the BZ newspaper reported on Monday. To date, the death toll in France from the coronavirus is 28,108, with the total number of cases reaching 142,411.
And antibodies "significantly exceeded" those in recovered patients for people on the middle dose.
The first 45 volunteers for the vaccine trial were divided into three groups, with each group getting a different dose of the vaccine. Data on neutralizing antibodies for the other participants were not yet available, Moderna said.
A Phase 2 trial has already been given the go-ahead by the Food and Drug Administration.
The development of a vaccine usually takes years but the coronavirus pandemic, which has caused more than 315,000 deaths, has given unprecedented urgency to the search.
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CDPH acknowledged the allocation for remdesivir, a COVID-19 treatment touted as the "standard of care" by Dr. Unfortunately, some of these trials have been overshadowed by doubts about the supply of the drug.
Phase 2 trials are expected to begin within days.
The company acknowledged that a single participant at 100 µg experienced grade 3 erythema (redness) around the injection site, while at the 250 µg dose level, three participants showed grade 3 systemic symptoms, but only following the second dose. The results reported Monday come from an initial analysis of a Phase I study primarily created to see if the vaccine is safe.
"We're doing our best to make it as many millions [of doses] as possible [when the time comes]", Zaks says to the Times.
"We're quite pleased with the breadth of the immune response so far", Dr. Hoge said on "CBS This Morning".
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In last week's report, the Illinois Department of Public Health said the nursing home had 40 probable or confirmed cases. There also were two new reported cases of detainees contracting COVID-19 at the U.S.
Reducing the dose required to produce immunity could help spare the amount of vaccine required in each shot, meaning the company could ultimately produce more of the vaccine.