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Moderna Inc. said its Covid-19 vaccine was 94.5% effective in a preliminary analysis of a large late-stage clinical trial, another sign that an accelerated search by scientists and pharmaceutical companies is paying off with powerful new tools that They could help control a worsening pandemic.
The highly positive reading comes just one week after a similar shot developed by Pfizer Inc. and BioNTech SE was found to be more than 90% effective in an interim analysis.
Both injections are based on a technology called messenger RNA that has never been used to make an approved vaccine. Soon, millions of people around the world could be saved from the disease thanks to advances.
A preliminary analysis of data from more than 30,000 volunteers showed that Moderna’s vaccine prevented virtually all symptomatic cases of Covid-19, the disease caused by the coronavirus, the company said in a statement Monday.
Moderna shares were up 12% in pre-market trading in the US, while in Europe, the Stoxx 600 index was up 1.4%. The rally in global stocks after the news represented around $ 120 billion in market value added to the MSCI All Country World index.
Only five participants who received two doses of the vaccine became ill, compared with 90 cases of coronavirus in participants who received a placebo, according to a review by an independent data safety monitoring board appointed by the National Institutes of Health of USA
The vaccine also appeared to be effective in preventing the most serious Covid-19 infections. T
There were no serious cases here among the people who received the vaccine, compared with 11 in the volunteers who received placebo injections, according to the Moderna statement.
“What touched me the most today was the serious illness,” Moderna CEO Stephane Bancel said in an interview. “That to me is a game changer.”
The results come at a time when control of the pandemic is tightening. The United States surpassed 11 million coronavirus cases on Sunday as Florida reported the most new infections since July and new cases in California hit a three-month high.
Deaths and hospitalizations are also increasing. Europe has also seen cases skyrocket as much of the world prepares for what is expected to be a terrible winter.
While the results are preliminary, both Moderna and Pfizer are expected to apply for emergency use authorization from the US Food and Drug Administration if further study shows their vaccines are safe.
In its statement, Moderna said it could seek the go-ahead from regulators in the coming weeks.
The company said it would expect an emergency clearance to be based on a final analysis containing 151 cases, along with two months of safety tracking data that US regulators want to see. Final data is expected later this month.
Modern, based in Cambridge, Massachusetts, received $ 955 million from the US Operation Warp Speed program to develop its vaccine, and the US agreed to pay up to $ 1.53 billion to purchase the supply of the injection.
Pfizer has said it did not receive any federal funding to develop its vaccine, although it did reach a supply deal with the United States worth nearly $ 2 billion.
Shot stability
Once a vaccine is licensed, distribution is expected to be a major challenge. Handling some of the vaccines being studied is complicated: for example, Pfizers must be stored at ultra-cold temperatures for up to a few days before use, a requirement that adds logistical obstacles for the states that will be in charge of supervising the inoculation. effort.
Moderna said Monday that the new stability data showed that its vaccine is stable at refrigerator temperature for 30 days, much longer than the previously estimated seven days.
For long-term storage, it can be kept in freezers, although it does not need the special facilities required for the Pfizer vaccine.
Both the Moderna and Pfizer vaccines are based on mRNA technology designed to transform the body’s own cells in vaccine manufacturing factories. Once injected, the vaccines instruct cells to make copies of the coronavirus spike protein, stimulating the creation of protective antibodies.
Analysis of Moderna’s data found no significant security concerns, the company said. He said that some participants had severe fatigue, muscle pain, joint pain and headaches after receiving the vaccine, although the side effects were generally short-lived.
Bancel said the data security monitoring board met at 10 a.m. Sunday and he anxiously checked his email every five minutes until he heard early in the afternoon that they had results and got on a video call to hear them.
The result “is a great milestone” for messaging RNA technology, Bancel said. “It shows that mRNA can be a drug.”
Emerging cases
In vaccine trials, a certain number of volunteers, a percentage of whom receive a placebo, must be infected to determine if the vaccine works. That’s easier to do with the pandemic in the United States. The United States has recorded more than 100,000 new infections every day since Nov. 5, according to data from Johns Hopkins University compiled by Bloomberg.
The same explosion of Covid-19 cases that helped Pfizer get results for its vaccine trial on November 9 helped accelerate Moderna’s trial. Moderna said Nov. 11 that her study had racked up more than 53 infections, allowing a preliminary analysis to begin.
Infections were piling up so fast in the trial that Moderna’s analysis ended up based on 95 cases, the company said.
Bancel said that at the rate that cases are accumulating, Moderna should obtain the final 151 cases by the end of the month, allowing it to complete a final analysis and request an emergency use authorization.
Moderna’s final stage test began on the same day as Pfizer’s in late July. The company was slightly behind Pfizer in large part due to structural differences in the studies. The two doses of Moderna’s vaccine are given four weeks apart; The two doses of Pfizer are given over three weeks.
Read: How a Covid-19 Vaccine is Approved in South Africa
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