On Monday, Moderna Inc said that its experimental vaccine was almost 94.5% effective in preventing COVID-19 based on provisional data from a late-stage clinical trial. It has become the second U.S. company in just one week to report results which far exceed the expectations.

Along with Pfizer Incs vaccine that has also shown to be almost 90% effective with pending more safety data and regulatory review, the United States will have two vaccines ready for authorization of emergency use in December with nearly 60 million doses of vaccine available by this years end.

Next year, the U.S. government might have access to over 1 billion doses from the two vaccine makers, needed for the countrys 330 million residents. Both the vaccines are built using new technology known as messenger RNA or mRNA, which represent powerful new tools to battle a pandemic which infected 54 million people globally and had killed 1.3 million people. The good news comes at a time when coronavirus cases are increasing and hitting new records in the United States and are pushing few European countries again into lockdowns.

Moderna President Stephen Hoge said during a telephone interview that they are going to have a vaccine which can stop COVID-19. Modernas provisional analysis was based on 95 infections among trial participants who had received either a placebo or the vaccine dose. Out of those, only five infections had occurred in those participants who received the vaccine that was administered in two shots with 28 days apart.

A significant advantage of Modernas vaccine is that it does not require ultra-cold storage like Pfizers, thus making it easier to distribute. Moderna assumes it to be stable at standard refrigerator temperatures of 2 to 8 degrees Celsius (i.e. 36 to 48°F) for 30 days and can be stored up to 6 months at -20 degrees Celsius. Pfizers vaccine can be shipped and stored at minus 70 degrees Celsius. At standard refrigerator temperatures, the vaccine could be stored for up to 5 days.

The data from Modernas 30,000 participant-strong trial revealed that the vaccine can prevent cases of severe COVID-19. This is a question which still remains with the Pfizer vaccine. Moderna is part of the U.S. governments Operation Warp Speed program and is expecting to manufacture around 20 million doses of the vaccine for the United States by this year end. Millions of doses the company has already made is ready to ship after receiving FDA authorization.

The 95 cases of COVID-19 had included numerous key groups who are at increased risk for severe infection. It included 15 cases in adults aged 65 years and older and 20 cases in participants from racially diverse groups. The most side effects were from mild to moderate. A significant proportion of participants did experience severe aches and pains after taking the 2nd dose that included about 10% who had severe fatigue interfering with daily activities while another 9% had severe body aches. The company said that most of these complaints were mostly short-lived. Moderna expects to have sufficient safety data that was required for U.S. authorization in the next week and also expects to file for an emergency authorization for its use.

The United States has the worlds maximum number of coronavirus cases and deaths with more than 11 million infections and approximately 250,000 deaths. The Trump Administration has mostly relied on development of vaccines and treatments as its answer to the ongoing pandemic. Moderna has received almost $1 billion for research and development funding from the U.S. government and has a $1.5 billion agreement for 100 million doses. The U.S. government has an option for another 400 million doses also. The company expects to have 500 million and 1 billion doses in 2021, divided between its U.S. and international manufacturing sites and dependent partly on demand.

The U.S. government has already announced that COVID-19 vaccines would be provided free to Americans, whether they have health insurance or are uninsured or are also covered by government health programs such as Medicare. Moderna said it will also use its data to seek authorization in Europe and other regions too.

China and Russia have already begun their vaccinations. Russia has licensed its "Sputnik-V" COVID-19 vaccine for domestic use in August before it had released data from their large-scale trials. It said on 11th November that their vaccine was 92% effective based on 20 infections in the large trial.

Source: ET Healthworld