How mRNA technology works in Pfizer, Moderna coronavirus vaccines

Joanna Estrada
November 22, 2020

Pfizer Inc. and BioNTech SE will request emergency authorization of their Covid vaccine on Friday, and it could take at least three weeks for a U.S. Food and Drug Administration decision as trial data is probed by agency staff and outside advisers.

The advisory panel is expected to consider whether the vaccine was shown to work safely in certain racial, ethnic and age groups, and give a recommendation whether the vaccine should be authorized and for whom.

Echoing the positive message, EU Commission chief Ursula von der Leyen said the bloc could approve both vaccines "as early as the second half of December".

"I am confident that if everything goes well, and we have a very organized vaccine supply, that we could have a normal summer and winter 2021", Şahin said.

Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95 percent effective.

The vaccine has been tested on more than 40,000 people in six different countries, including the U.S. and Germany, who have each received a part of the virus genome that forces the body to develop natural immune defenses.

A green light would cap the fastest vaccine development program ever in the West, going from laboratory to authorization in less than a year.

"While the mortality rates remain low, some experts worry that a rise in cases among children may mean a rise in cases of Multisystem Inflammatory Syndrome in Children (MIS-C) later", says USA Today. "Pfizer has said it didn't receive any federal funding to develop its vaccine, though it has a supply agreement with the US worth almost $2 billion".

An FDA advisory committee tentatively plans to meet December 8-10 to discuss the vaccine, a source familiar with the situation told Reuters, though the dates could change.

Other contenders in late-stage testing like AstraZeneca/Oxford University and Johnson & Johnson are using the traditional approach of injecting people with modified viruses to trigger an immune response. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.

The news was especially welcome with the virus again running rampant around the world, setting records for new infections and hospitalizations nearly daily. Both companies have already begun producing doses, banking on the fact that their vaccines would be effective, but that manufacturing still won't churn out enough doses to meet demand this year. It also has agreements with the European Union, Germany and Japan where distribution could begin next year.

Pfizer reported 3.8% of the recipients felt fatigue and 2% experienced headache, based on preliminary data from its Phase 3 trial.

The FDA has said it expects manufacturers to apply for regular approval as soon as possible.

Moderna's vaccine needs to be stored at minus 20C for up to six months and kept in a standard fridge for up to a month. Final results and safety data are expected in the coming days or weeks. The Moderna vaccine is said to be 94.5% effective. "The big message is that we have an additional tool [in the form of vaccines] for fighting COVID-19, but we don't have a tool to replace everything we do just yet", says Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Health Secretary Matt Hancock, speaking at a Downing Street news conference, revealed the government has now taken the "first step" for authorising a COVID-19 vaccine in the UK.

Other reports by Click Lancashire

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