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Moderna COVID-19 vaccine authorized by FDA for emergency use in US
The FDA has authorized Moderna’s COVID-19 vaccine for emergency use in the U.S. The first shots of the vaccine are expected to be given Monday.
Police, firefighters, teachers and grocery workers will be among those next in line for a COVID-19 vaccine, a Centers for Disease Control and Prevention advisory panel decided Sunday.
The committee voted 13-1 to recommend that Phase 1b include people 75 and older and front-line essential workers. Phase 1c will include people 65 to 74 and people 16 to 64 who have high-risk medical conditions, along with other essential workers.
“My hope is that these short-term recommendations will support efficiency and equity in every phase of vaccination until we can get to the time when all individuals have access to safe and effective vaccines in the U.S. and worldwide,” said Dr. Grace Lee, a professor of pediatrics at Stanford University School of Medicine and committee member.
The Advisory Committee on Immunization Practices began its deliberations Sunday morning and spent the day discussing who would follow front-line health care workers and people in long-term care facilities in receiving vaccines, a second phase that could begin in February. The committee is responsible for recommending who gets what vaccines when.
They made difficult decisions that were based on getting a vaccine as quickly as possible to people at the greatest risk of contracting COVID-19 and those who will suffer the most severe outcomes, said Dr. Sharon Fry of the Saint Louis University Medical School and a committee member.
“There are no perfect recommendations. and people will continue to become ill with this disease and die from the disease until there are adequate vaccines. So please, I will plead also for our leaders and the government to move quickly on this and support this effort,” she said.
There are now two COVID-19 vaccines in use in the United States. The Pfizer/BioNTech vaccine was authorized by the Food and Drug Administration on Dec. 11. The Moderna vaccine was authorized Friday and should begin arriving at hospitals on Monday.
The United States has created a phased vaccination plan for the coronavirus because there won’t be enough vaccine in the beginning of the rollout.
Phase 1a includes front-line health care workers and people in long-term care facilities.
“Essential workers are at high risk because of exposure, by virtue of being in contact with others, in performing their duties. Prevention of disease in essential workers may reduce transmission to others,” said Dr. Kathleen Dooling, a CDC physician who is co-lead on the advisory committee’s COVID-19 Vaccines Working Group.
These workers are considered essential to the functioning of society and are at substantially higher risk of exposure to SARS-Co/V-2, the virus that causes COVID-19. They make up about 30 million people among these groups:
- First responders such as firefighters, police
- Teachers, support staff, day care workers
- Food and agriculture workers
- Manufacturing workers
- Correction workers
- U.S. Postal Service workers
- Public transit workers
- Grocery store workers
Tho essential workers in Phase 1c make up about 57 million people and would include:
- Public health workers
- Transportation and logistics workers
- Food service workers
- Construction workers
- Finance workers
- IT & Communications workers
- Energy workers
- Media workers
- Legal workers
- Public safety engineers
- Water and wastewater workers
Medical conditions with sufficient evidence to have been associated with severe COVID-19 disease include:
- Type 2 diabetes
- COPD, or chronic obstructive pulmonary disease
- Heart condition
- Chronic kidney disease
- Immunocompromised state from solid organ transplant
- Sickle cell disease
- Smoker (current or with a history of smoking)
Phase 2 would include all people 16 and over who were not in Phase 1 who are recommended for the vaccination. That means people 16 and over with high-risk medical conditions.
Because vaccine supplies are initially limited, Phase 1b isn’t expected to begin until February.
Operation Warp Speed, the White House COVID-19 vaccine and treatment accelerator, has said it expects to distribute 20 million doses in December, 60 million in January and 100 million by February. That’s 180 million doses by the end of February, which means 90 million people would be fully vaccinated. (Both the Pfizer/BioNTech and Moderna vaccines require two doses.)
Exactly how the 20 million doses will be distributed by the end of the month is not clear. Last week, 2.9 million doses of the Pfizer/BioNTech vaccine were distributed. This week, another 2 million doses of the Pfizer vaccine will be distributed, together with 5.9 million doses of the Moderna vaccine.
More vaccines are in the pipeline. Another candidate, from Johnson & Johnson, fully enrolled its large-scale human trial Thursday and expects to report its first safety and effectiveness data in January.
A fourth, created by AstraZeneca and Oxford University, is a few weeks behind, and a fifth candidate, by vaccine developer Novavax of Gaithersburg, Maryland, is expected to begin its major U.S. trial shortly.
If all or most of these come through, there should be plenty of vaccine by the end of next summer to cover every American who wants one.
Contributing: Karen Weintraub