U.S. experts are meeting on Thursday to decide whether to recommend approval of Moderna’s Covid-19 vaccine, potentially paving the way for deployment early next week.
The meeting comes after the Pfizer-BioNTech vaccine received emergency use authorization and the first three million doses were distributed in the worst-affected country in the world this week.
Thursday’s meeting will be webcast live to the public and will conclude with a vote of two dozen independent scientists and industry representatives.
If the panelists vote in favor, as is widely expected, the Food and Drug Administration is expected to give the green light shortly thereafter, which could make the United States the first country to approve the Moderna vaccine.
The small Massachusetts biotech company partnered with scientists from the U.S. National Institutes of Health to produce the product and began work in January just days after Chinese officials shared the SARS virus genome -CoV-2.
Moderna received more than $ 2.5 billion from the US government for its efforts and pledged six million doses in the first wave.
A clinical trial involving 30,400 people found it to be 94.1% effective in preventing Covid-19 compared to placebo, with slightly better performance in young adults than in the elderly.
An FDA review of all available data found that there were “no specific safety issues identified that would prevent the issuance of an EUA (Emergency Use Authorization). ”
Moncef Slaoui, chief advisor to Operation Warp Speed, told reporters on Wednesday he was impressed with the level of protection against the disease the vaccine provided 10 to 14 days after even the first of two doses.
“The second thing that’s really interesting is the apparent protection against infection,” which turned out to be 60-65%.
A major concern has been how well vaccines will prevent people from being infected asymptomatically, and Slaoui said he expected the effectiveness to become even higher after the second dose, given 28 days later.
“I think it would be very important from a public health point of view,” he said.
– Messenger RNA –
The most common side effects associated with the drug, called mRNA-1273, were pain at the injection site in about 90 percent of cases; fatigue in 70%, headache in 60%, muscle pain in 60%, joint pain in 45% and chills in 45%.
Few of these effects were classified as “serious” and, when they were, they tended to occur more in young people than in older people.
Lymphadenopathy, or swollen lymph nodes, occurred in 1.1% of the vaccinated group compared to 0.6% of the placebo group.
There was an imbalance in allergic reactions, which occurred in 1.5 percent of the vaccinated population versus 1.1 percent of the unvaccinated.
But none were classified as severe or anaphylactic.
The frequency of life-threatening events was low, around one percent in each group, without the vaccine being the cause.
To date, there have been three reports of Bell’s palsy – facial palsy, most often temporary – in the vaccinated group and one in the placebo group.
The Pfizer trial saw four people contract Bell’s palsy in the vaccine group, and none in the placebo group.
The FDA said there was not enough information to determine that either vaccine was the cause.
The Pfizer and Moderna vaccines use mRNA (messenger ribonucleic acid) molecules to cause human cells to express a surface molecule of the novel coronavirus.
This simulates an infection and trains the immune system to be prepared in case it encounters the real virus.
MRNA is enclosed in fatty particles.
The two companies used a slightly different formulation resulting in different cold storage requirements: -70 degrees Celsius (-94 degrees Fahrenheit) for Pfizer; -20 degrees Celsius (-4 Fahrenheit) for Moderna.
Moderna has applied for approval for those over 18, while Pfizer’s approval is for those over 16.
The United States hopes to immunize 20 million people by December, with health workers and long-term care residents on the front lines.
© 2020 AFP