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 a frenzied hunt by scientists and pharmaceutical companies with powerful new tools is paying off could help control a worsening pandemic.
The very positive indication comes just one week after a similar uptake developed by Pfizer Inc. and BioNTech SE was more than 90% effective in an interim analysis. Both recordings are based on a technology called messenger RNA, which has never been used to make an approved vaccine. Soon, the breakthroughs could save millions of people around the world from disease.
An initial analysis of data from more than 30,000 volunteers found that Moderna’s vaccine prevented virtually all symptomatic cases of Covid-19, the disease caused by the coronavirus, the company said in a statement on Monday.
Moderna shares rose up to 15% in New York. The post-news rally in global equities added approximately $ 567 billion in market value for the MSCI All Country World Index.
Only five participants who received two doses of the vaccine got sick, compared to 90 coronavirus cases in participants who received a placebo. This was the result of a review by an independent data security supervisory body appointed by the US National Institutes of Health.
The vaccine also appeared to be effective in preventing the most serious Covid-19 infections. There were no severe cases in people who received the vaccine compared with 11 in volunteers who received placebo shots, according to Moderna.
The results come at a time when the grip of the pandemic is tightening. The US exceeded 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 hospital stays are also increasing. Europe has also seen cases where much of the world is prepared for what is likely to be a dire winter.
Although the results are preliminary, both Moderna and Pfizer are expected to seek emergency approval from the U.S. Food and Drug Administration if further studies show their vaccines are safe. In its statement, Moderna said it could seek approval from regulators in the coming weeks.
“The results of this study are really impressive,” said Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases, on a conference call with reporters. The effectiveness against serious diseases “is really impressive”.
What Bloomberg Intelligence Says
“Moderna’s mRNA-1273 vaccine, which has an impressive 94.5% effectiveness in preventing Covid-19 cases, is in our view on par with Pfizer-BioNTech’s mRNA vaccine BNT162b2. In addition, the less stringent ones deliver Distribution and shipping requirements of mRNA-1273 give it an edge over its rival, although both are deployed in the face of production constraints and their long-term protection is still unknown, “said Sam Fazeli, Senior Pharma Analyst.
The company expects an emergency clearance to be based on a final analysis of 151 cases and two months of safety data that U.S. regulators want to see. These final dates are expected later this month.
Moderna, of Cambridge, Massachusetts, received $ 955 million from the US Operation Warp Speed program to develop its vaccine. The country has agreed to pay up to $ 1.53 billion to purchase the shot. Pfizer said it did not receive federal funding to develop its vaccine, despite the fact that it had a supply deal with the United States worth nearly $ 2 billion.
Moderna expects to make 20 million doses of its vaccine by the end of the year, enough to vaccinate 10 million people. This first batch goes to the USA.
Government officials said on the conference call today that they expect at least 20 million doses of the Pfizer vaccine in the US by the end of the year, which will be enough for another 10 million recipients. Pfizer expects to produce up to 50 million doses of its vaccine by the end of 2020.
Once a vaccine is cleared, distribution is expected to be a significant challenge. Some of the recordings examined are complicated to handle: for example, Pfizer must be stored in extremely cold temperatures for up to a few days before use. This creates logistical hurdles for states that are responsible for monitoring the vaccination effort.
Moderna said Monday that new data showed its vaccine is stable for 30 days at refrigerator temperatures, much longer than the previous seven-day estimate. It can be kept in freezers for longer term storage but does not require the special facilities required for the Pfizer vaccine.
“Every pharmacy, doctor’s office, every hospital” can keep a vaccine in a regular refrigerator, Bancel said in an interview on Bloomberg Television on Monday. The stability of the vaccine at such temperatures will “have a major impact” on the ability to spread it widely.
Both Moderna and Pfizer vaccines are based on mRNA technology, which is used to convert the body’s own cells into factories to make vaccines. Once injected, the vaccines instruct the cells to make copies of the coronavirus spike protein, which stimulates the production of protective antibodies.
Analysis of Moderna’s data did not reveal any material security concerns. Some participants experienced severe fatigue, muscle pain, joint pain, and headache after receiving the vaccine, although the side effects were generally short-lived.
According to Bancel, the data security monitoring body met at 10 a.m. on Sunday. The CEO said he anxiously checked his email every five minutes until he heard they had results in the early afternoon and received a video call to hear them.
The result “is a major milestone” for messenger RNA technology, Bancel said. “It shows that mRNA can be a drug.”
In vaccine trials, a certain number of volunteers – a percentage of whom will receive a placebo – must become infected to see if the vaccine is working. That is easier to achieve with the pandemic in the US. According to data from Johns Hopkins University compiled by Bloomberg, the country has recorded more than 100,000 new infections daily since November 5th.
The same explosion of Covid-19 cases that helped Pfizer get results for its November 9 vaccine study helped accelerate the Moderna study. Moderna said on Nov. 11 that its study had accumulated more than 53 infections so a preliminary analysis could begin.
Infections accumulated so quickly in the study that Moderna’s analysis was based on 95 cases, the company said.
Bancel said cases are mounting. Moderna should receive the last 151 cases by the end of the month so it can do a final analysis and file an emergency clearance.
The process in the final phase of Moderna began on the same day as Pfizer’s in late July. The company was slightly behind Pfizer mainly due to structural differences in the studies. The two doses of Moderna’s vaccine are given four weeks apart. Pfizer’s two doses are given over three weeks.