Moderna Covid vaccine candidate: Moderna shares rose 15% in New York.
Moderna Inc. said its Covid-19 vaccine was 94.5% effective in a preliminary analysis from a large, late-stage clinical trial, another sign that a rapid hunt by scientists and pharmaceutical companies is bearing its fruits with powerful new tools that could help control a worsening pandemic.
The very positive reading comes just a week after a similar shot developed by Pfizer Inc. and BioNTech SE was found to be over 90% effective in an interim run. Both injections rely 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 spared the disease thanks to the breakthroughs.
An initial 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 rose 15% in New York. The rally in global equities after the news accounted for around $ 567 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 oversight committee appointed by the National Institutes of Health. United States.
The vaccine also appears to be effective in preventing the most serious Covid-19 infections. There were no serious cases among people who received the vaccine, compared to 11 among volunteers who received placebo injections, according to Moderna’s statement.
The results come at a time when the grip 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 braces for what is expected to be a harsh winter.
Although the results are preliminary, Moderna and Pfizer are expected to seek emergency use authorization from the United States Food and Drug Administration if further study shows their vaccines to be safe. In her statement, Moderna said she may seek the green light from regulators in the coming weeks.
“The results of this trial are really striking,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a conference call with reporters. The effectiveness against serious illness “is really quite impressive”.
What Bloomberg Intelligence says
“Moderna vaccine mRNA-1273, which shows an impressive 94.5% efficacy in preventing Covid-19 cases, gives it a par with Pfizer-BioNTech’s BNT162b2 mRNA vaccine, at our notice. In addition, the less stringent distribution and shipping requirements provide mRNA-1273 an advantage over its rival, although both will be used given production constraints, while their long-term protection is still unknown ”, said Sam Fazeli, senior pharmaceutical analyst.
The company said it would expect an emergency clearance to be based on a final analysis containing 151 cases, as well as two months of safety tracking data that U.S. regulators want to see. These latest data are expected later this month.
Moderna, based in Cambridge, Mass., Received $ 955 million from the U.S. Operation Warp Speed program to develop its vaccine, and the country has agreed to pay up to $ 1.53 billion to purchase the vaccine. Pfizer said it had received no federal funding to develop its vaccine, despite having reached a supply deal with the United States worth nearly $ 2 billion.
Moderna plans to manufacture 20 million doses of its vaccine by the end of the year, enough to immunize 10 million people. This initial batch will go to the United States.
Government officials said on the conference call today that they also expect to have at least 20 million doses of the Pfizer vaccine, sufficient for an additional 10 million recipients, available in the United States by the end. of the year. Pfizer said it plans to produce up to 50 million doses of its vaccine by the end of 2020.
Shooting stability
Once a vaccine is licensed, distribution should be a big challenge. The management of some of the injections under study 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 hurdles for states that will be responsible for supervise the inoculation effort. .
Moderna said Monday that new data showed her vaccine was stable at refrigerator temperature for 30 days, much longer than the previous estimate of seven days. For longer term storage, it can be stored in freezers, although it does not require the special facilities required for Pfizer vaccine.
“Every pharmacy, doctor’s office, hospital” has the capacity to store a vaccine in a regular refrigerator, Bancel said in an interview with Bloomberg Television on Monday. The stability of the vaccine at such temperatures will have “a huge impact” on its ability to distribute it widely.
Moderna’s and Pfizer’s vaccines are both based on mRNA technology designed to turn the body’s own cells into vaccine factories. Once injected, the vaccines instruct cells to make copies of the coronavirus spike protein, stimulating the creation of protective antibodies.
Moderna Coronavirus Vaccine: The candidate would be 94.5% effective.
Analysis of Moderna’s data did not reveal any significant security issues, the company said. He said 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 oversight committee met at 10 a.m. on Sunday. The CEO said he anxiously checked his emails every five minutes until he learned early in the afternoon that they had results and made a video call to hear them .
The result “is a milestone” for messenger RNA technology, Bancel said. “It shows that mRNA can be a drug.”
Outbreak
In vaccine trials, a number of volunteers – a percentage of whom are given a placebo – must be infected in order to determine if the vaccine works. This is easier to accomplish with the outbreak of the pandemic in the United States. The country 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 achieve results for its vaccine trial on November 9 helped speed up Moderna’s trial. Moderna said on November 11 that his study had accumulated more than 53 infections, which allowed a preliminary analysis to begin.
The infections accumulated so quickly in the trial that Moderna’s analysis ended up being based on 95 cases, the company said.
Bancel said that at the rate that accumulates, Moderna is expected to obtain the last 151 cases by the end of the month, which would allow it to complete a final analysis and file an emergency use authorization.
Moderna’s final trial began on the same day as Pfizer’s at the end of July. The company lagged behind Pfizer slightly 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.
