Just a week after the historic first approval of a Covid-19 vaccine in the US, Moderna is the second company to come to Pfizer with an FDA-approved vaccine for Covid-19. The full pre-approval review of the FDA vaccine and related biological products for the Moderna vaccine, officially known as mRNA-1273, is available on YouTube.
Moderna’s vaccine, like Pfizer’s, uses mRNA instead of a live or modified virus. As the company explains, they “make mRNA vaccines using the sequence of the virus, not by working on the virus itself.” An mRNA vaccine “teaches” the body to identify its own antibodies, small proteins that the immune system uses to hunt, and invaders. Here’s how the FDA described the process in a press release:
“The Moderna COVID-19 vaccine contains messenger RNA (mRNA), genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus mRNA, which instructs the cells in the body to make the virus’ characteristic “spike” protein. After a person receives this vaccine, their body makes copies of the spike protein, which does not cause disease but causes the immune system to learn to respond defensively, which creates an immune response against SARS-CoV-2. “
This is a milestone for Moderna and marks both the first time a product has been launched and the first time it has received FDA approval. The company relied on information and experience from a previous collaboration with the NIH on another coronavirus vaccine. Your vaccine against MERS-CoV never went beyond research.
Moderna’s vaccine is given in two doses one month apart. Unlike the Pfizer vaccine, it can be transported in a regular refrigerator and is stable in that environment (36 to 46 ° F) for 30 days. This should allow easier transportation to smaller clinics and rural areas.
According to a press release from Moderna, their vaccine has achieved a 94.1% effectiveness rate. The FDA Briefing Document provides detailed information on the rigorous safety tests and clinical trials the vaccine has undergone.
Moderna’s Phase 3 clinical study enrolled 30,400 participants aged 18 and over. The FDA reports that side effects are “injection site pain (91.6%), fatigue (68.5%), headache (63.0%), muscle pain (59.6%), joint pain (44.8%) and Chills (43.4%) included; Serious side effects occurred in 0.2% to 9.7% of participants, were more common after dose 2 than after dose 1, and were generally less common in participants aged 65 and over compared to younger participants. “
173 participants (1.1%) in the vaccine group and 95 participants (0.63%) who received the placebo reported lymph node swelling. Three people who received the vaccine and one person who received the placebo reported Bell’s palsy facial palsy.
Moderna’s application, unlike Pfizer’s, did not include anyone under the age of 18. The FDA committee had 20 votes in favor and one abstention. This individual vote came from Dr. Michael Kurilla, PhD, quoted CNBC as saying, “In the midst of a pandemic and with limited vaccine supplies, a blanket statement for people 18 and older is just too broad. I’m not convinced that the benefits for all ages outweigh the risk. “
After the emergency vaccine is approved, distribution begins almost immediately. The New York Times reports that 5.9 million doses are expected to be dispensed over the next week. Deliveries start on Sunday and reach hospitals on Monday. The distribution is managed by the federally funded Operation Warp Speed.
Anthony Fauci, MD, director of the National Institute for Allergies and Infectious Diseases, has expressed hope for speedy vaccinations. He told the Today Show, “I would assume we would probably see gunshots in the arm early next week. I would hope Monday or Tuesday … But very soon, literally within a few days.”
The US government has ordered 100 million doses of Moderna’s vaccine pending approval, delivery by March, another 100 million by June, and an additional option for 300 million doses. In total, Moderna has been tasked with providing more than 470 million cans to governments around the world. The company recently began studies on teenagers to approve vaccinations for younger people in time for the 2021-2022 school year.
Take them home
Moderna’s vaccine, once approved for the emergency, has the potential to become an effective tool in the fight against Covid-19. The addition of a second vaccine means millions more Americans can be protected from the disease. The milder storage restrictions make this vaccine easier to distribute across the country and potentially reach a wider variety of areas – especially those that do not have the facilities to distribute and store Pfizer’s offerings.
Sean Marsala is a Philadelphia, Pennsylvania-based health journalist. He loves technology, usually reads, surfs the internet, and explores virtual worlds.