A candidate vaccine for Covid-19 developed by the drug maker Moderna appears to generate an immune response similar to the response seen in people who have been infected by the virus and recovered, the company said Monday.
In a Phase 1 trial, eight patients who received two doses of the vaccine at the lowest and middle doses tested — 25 and 100 micrograms — developed neutralizing antibodies to the virus at levels similar to people who had recovered from infection, the company said in a statement.
The data were limited and from only a small number of participants in the trial, led by the National Institute of Allergy and Infectious Diseases. But they are still likely to be seen as encouraging. Research aimed to develop a vaccine against SARS, a related virus responsible for a 2002-2003 outbreak, showed that neutralizing antibodies are pivotal for achieving protection.
Moderna is developing the vaccine in conjunction with the NIAID’s Vaccine Research Center.
“These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 μg,” said Tal Zaks, Moderna’s chief medical officer.
The statement noted that a new arm of the trial is being established to test a 50-microgram dose, which may suggest concern that the 25-microgram dose may be too low.
As the vaccine’s developers work to establish a dose, they must balance the need to achieve protection in individuals — including seniors, who are at highest risk in this pandemic but whose immune systems do not respond as well to vaccines — with the goal of using as little vaccine as possible per person to stretch out what will be limited supplies.
“I think 25 [micrograms] gets us there but you always want to have somewhat of a margin,” Zaks told STAT in an interview.
“The sense is at the end of the day we’re going to narrow it down on somewhere between 25 and 100,” he said. “It’s going to be really hard math for us.”
While some experts wanted more detail before commenting on the data, others saw it as a positive sign for this vaccine.
“The neutralizing antibody and safety results from the Phase 1 clinical study are promising for the Moderna mRNA vaccine candidate and supportive to proceed forward with the planned Phase 2 studies,” Robin Robinson, chief scientific officer at RenovaCare, told STAT. Robinson is a former director of the Biomedical Advanced Research and Development Authority.
Vaccination with the candidate vaccine, provisionally labeled mRNA-1273, also prevented viral replication in the lungs of mice in preclinical testing, the company’s statement said.
A Phase 2 trial has already been given the go-ahead by the Food and Drug Administration. CEO Stéphane Bancel said the company is pushing forward with a Phase 3 trial set to start in July and is ramping up its capacity to manufacture the vaccine.
“We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2,” Bancel said, referring to the virus that causes Covid-19.
The company’s statement suggested the vaccine was well-tolerated in people who received it in the Phase 1 dosing trial. One of the people in the 100-microgram arm developed redness at the injection site that met the criteria for a Grade 3 adverse event. And three volunteers in the highest dose arm — 250 micrograms — developed Grade 3 systemic reactions after receiving the second of two doses. There were no Grade 4 or life-threatening adverse events recorded in the trial.
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. There were 45 people involved in these three arms, though neutralizing antibody data are only available at this point for the first four patients each of the 25 microgram and 100 microgram cohorts.
People who received two doses at the 25 microgram level developed binding antibodies at levels consistent with those seen in the blood of people who have recovered from Covid-19 infection, the statement said. People who received two doses at 100 microgram had binding antibody levels that “significantly exceeded” the levels seen in the blood of Covid-19 survivors.
This is good work done as we enter 6months since the outbreak. I think China has some secrets over this since they had the first exposure
Looks encouraging. Keep it up
The Moderna events are the ultimate example of unbridled US corruption. 1) Moderna hypes an insufficiently tested vaccine to over-eager “get this over with” gullibles. 2) Results of a mini-“trial” sky-rocket the stock. 3) The Promotor (former Moderna man still holding stocks) sells pumped-up stocks. 4) Moderna raises an extravagant amount of funding based on the sky-high stock price. 5) Moderna reaps billions later (IF the vaccine cuts it). REALLY ?? can all the profiteering scumbags get away with it?? ONLY IN AMERICA !!!! Utter, despicable, outrageous corruption. Whatever leader allows this to happen is an idiot. Whatever citizens allow this to happen are dumb sheep. America is going off the deep end. And the whole world is laughing its head off.
100% agreed. The evidence was so patently weak yet Stat News in desperation and false hope reported it as a positive early finding?! WTF it was inconclusive and the company touting it as a success is completely laughable. People are so desperate they buy into it despite the glaring evidence. People on here wanting to volunteer. This is incredibly sad and the company, I hope will be suspended for the fact that their big insider investor was dumping stocks ahead of the news. Corruption and a very sad, gullible public.
Gord- You don’t seem to know how biotech works. It is almost ALWAYS the case that the company will issue a short press release with a limited amount of top line data at an interim data release. This data was enough to move the entire stock market, and you can bet there were hackers from every country in the world trying to break into the computers of the company and the investigators (let alone any conference or journal their results might get submitted to) to profit from insider trading. To protect honest investors, it is standard practice to issue press releases with the top line data. (Indeed, the investors or the Trump administration may want to chip in some extra money, but do you really expect Trump’s people to be able to keep secrets from insider traders?) Usually clinical investigators want to present at medical conferences and publish in fancy journals that both insist on publishing all the gory details first– Not after they’ve been fully disclosed by a company. I’ve been closely following a number of biotechs for years, and that’s just the way it works. The author of that statnews article doesn’t appear to know that, nor does that clueless stat-quoted Yale prof, who needs to get out of the ivory tower more often.
Do we need to have rt PCR test before injecting vaccine? Or rapid dot test will be in consideration.
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