Moderna vaccine 94.5% effective in second breakthrough
In this file photo a view of Moderna headquarters is seen on May 8, 2020 in Cambridge, Massachusetts. US biotech firm Moderna on May 18, 2020 reported "positive interim" results in the first clinical tests of its vaccine against the new coronavirus performed on a small number of volunteers. The vaccine appeared to produce an immune response in eight people who received it, of the same amplitude as that observed in people infected with the virus, the company said, adding that phase 3 trials with a large number of volunteers would begin in July.
AFP/MADDIE MEYER/GETTY IMAGES NORTH AMERICA
Moderna vaccine 94.5% effective in second breakthrough
Issam Ahmed (Agence France-Presse) - November 16, 2020 - 9:06pm

WASHINGTON, United States — US biotech firm Moderna on Monday announced its experimental vaccine against COVID-19 was 94.5% effective, marking a second major breakthrough in the vaccine hunt.

Moderna released early results from a clinical trial with more than 30,000 participants, after US pharmaceutical company Pfizer and its German partner BioNTech last week said their vaccine was 90% effective. 

Both vaccine frontrunners are based on a new platform called messenger RNA, which is faster to produce than traditional vaccines and effectively turn human cells into vaccine factories.

"This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease," said Stephane Bancel, Moderna's CEO.

The company plans to submit applications for emergency approval in the US and around the world within weeks, and says it expects to have approximately 20 million doses ready to ship in the US by the end of the year.

Global infections from COVID-19 have soared past 54 million with more than 1.3 million deaths since the virus emerged in China late last year.

The Moderna vaccine, which was co-developed by the US National Institutes of Health, is given in two doses 28 days apart, and the preliminary results are based on 95 volunteers of the 30,000 who fell ill with COVID-19.

Of the 95, 90 had been in the trial's placebo group, and five in the group that received the drug, called mRNA-1273.

'Tremendously exciting'

There were 11 people who fell severely ill, all of whom were in the placebo group.

The vaccine was well tolerated, with the majority of side-effects classed as mild or moderate.

After the first dose, about three percent of people had injection site pain classed as severe. 

Among side-effects classed as severe after the second dose, about 10 percent had fatigue, nine percent had muscle pain, five percent had joint pain or headaches, four percent had other pain and two percent had redness at the injection site.

These adverse events were "short lived," according to a statement.

"This news from Moderna is tremendously exciting and considerably boosts optimism that we will have a choice of good vaccines in the next few months," said Peter Openshaw, a professor of experimental medicine at Imperial College London.

Crucially, Moderna also announced that its vaccine can remain stable at standard refrigerator temperatures of 2 degrees Celsius to 8 degrees Celsius (36 degrees Fahrenheit to 46 degrees Fahrenheit) for 30 days.

The company added it could be kept in long-term storage at standard freezer temperatures of -20 degrees Celsius (-4 degrees Fahrenheit) for up to six months.

Pfizer's vaccine, on the other hand, needs to be stored in deep-freezer conditions which could complicate supply chain logistics, particularly in less developed countries.

It is not yet clear how long lasting the protection will be from either the Moderna or Pfizer vaccines, nor how well they work for the elderly, the age-group at highest risk from COVID-19.

COVID-19 VACCINES MODERNA NOVEL CORONAVIRUS
As It Happens
LATEST UPDATE: December 4, 2020 - 12:39pm

Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."

This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)

December 4, 2020 - 12:39pm

Moderna plans to have 100 to 125 million doses of its COVID-19 vaccine available in the first quarter of 2021, the vast majority of which will go to the United States, the biotechnology company announces.

Between 85 and 100 million of the doses will be distributed in the United States, with the rest of the world receiving the remaining 15 to 25 million, the Cambridge, Massachusetts-based company says in a statement.

Moderna also confirms that it expects to have 20 million vaccine doses available in the US by the end of 2020. — AFP

December 2, 2020 - 3:42pm

Britain's approval of BioNTech-Pfizer's vaccine against COVID-19 marks a "historic moment" in the battle against the pandemic, the US pharma group's chief executive says Wednesday, after his company won the first such authorisation in the West.

"Today's Emergency Use Authorisation in the UK marks a historic moment in the fight against COVID-19," says Pfizer CEO Albert Bourla.

The US company and Germany's BioNTech adds that they expected further regulatory decisions from other countries "in the coming days and weeks". —  AFP

December 2, 2020 - 3:20pm

UK approves Pfizer-BioNTech vaccine for rollout from "next week".

Britain on Wednesday becomes the first country to approve Pfizer-BioNTech's COVID-19 vaccine for general use and says it would be introduced next week.

"The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech's Covid-19 vaccine for use," the department of health says in a statement.

"The vaccine will be made available across the UK from next week," the statement says, with priority groups including care home residents, health and care staff. —  AFP

December 2, 2020 - 2:41pm

President Rodrigo Duterte grants authority to the Food and Drug Administration to issue emergency use authorization for COVID-19 vaccines, Executive Secretary Salvador Medialdea says.

Duterte's Executive Order 121 also allows FDA to release emergency use authorization for COVID-19 drugs, prescribing conditions and for other purposes.

December 2, 2020 - 8:15am

The Pfizer and Moderna COVID-19 vaccines could be approved in a matter of weeks, but who in the United States will get them first? 

A high level panel of US experts on Tuesday voted that health care workers and residents of long-term care facilities should be prioritized in the first phase.

"I believe that my vote reflects maximum benefits, minimum harm, promoting justice and mitigating the health inequalities that exist, with regard to distribution of this vaccine," said Jose Romero, chair of the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention.

As the sequence continues though, US experts may differ from other countries in prioritizing "critical workers" who keep society running — potentially even before people at highest risk. — AFP
 

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