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Centers for Disease Control and Prevention vaccine advisers voted Sunday to recommend the Johnson & Johnson Covid-19 vaccine for the US. It is the first of the three authorized Covid-19 vaccines that comes in a single dose.
It is a vaccine one member called "highly effective."
The US Food and Drug Administration authorized the J&J vaccine on Saturday local time.
The CDC's Advisory Committee on Immunization Practices is a group of vaccine and public health experts that helps set guidelines for the CDC concerning the best practices with vaccinations. Members voted unanimously, with one recusal for a potential conflict of interest, to recommend the vaccine. They did not make any recommendations about specific groups who should receive the vaccine.
A vote from this group is one of the last federal regulatory steps needed before the vaccine can be sent out to states and vaccination programs. CDC Director Dr. Rochelle Walensky is expected to sign off on the recommendation quickly, and the federal government may then begin distributing the vaccine, perhaps as soon as Monday.
"I just want to state explicitly how very grateful I am that we now have three highly effective vaccines," said ACIP member Dr. Matthew Daley of the Institute for Health Research with Kaiser Permanente Colorado.
The vaccine, made by Johnson & Johnson's Janssen vaccine arm, can be kept at regular refrigerator temperatures, which experts said would make it much easier to distribute than vaccines made by Moderna and Pfizer/BioNTech.
"During a pandemic, the data show that the best utilization of resources is to employ all available vaccines with acceptable vaccine efficacy. This will save cost and lives," the CDC's Dr. Sara Oliver told the ACIP meeting. A single-dose vaccine has an advantage, particularly in settings where a second dose "would be challenging." For example, it could be used to help protect the homeless, people in the justice system, and those with limited access to health care like people who are homebound or live in rural areas, Oliver said.
The vaccine was tested in more than 44,000 people in the US, South Africa and Latin America. Globally, it was 66.1% effective against moderate to severe/critical Covid-19 at least four weeks after vaccination, according to an FDA analysis. In the US, it is considered 72% effective, and offered 86% protection against severe forms of the disease.
Overall, non-fatal serious adverse events were infrequent, according to the FDA's analysis, and there were no reported cases of anaphylaxis following vaccination in the trial. There have been a small number of severe allergic reactions with the Moderna and Pfizer/BioNTech vaccines. For example, in the first week of the Pfizer vaccine rollout, there were only 29 cases out of 1.9 million doses administered, according to the CDC.
More research is needed to now for sure, but the FDA analysis also hinted that the J&J vaccine may help prevent asymptomatic infections.
A January study from the CDC showed that most coronavirus cases are spread by people without symptoms. If a vaccine prevented asymptomatic infection, it might help reduce opportunities to transmit the disease -- not just keep the vaccinated from getting sick.
There is some concern among public health leaders that some people will think the J&J vaccine is "second class," because its efficacy is lower than the Moderna and Pfizer vaccines, but the experts say it is important that people remember these are totally different vaccines.
The J&J vaccine was tested at a time when there were more variants in circulation. Tested in South Africa and in Brazil, an FDA analysis found that the majority of the Covid-19 cases in the J&J trials were due to variants that are thought to be more contagious.
"The Johnson & Johnson vaccine was tested against the South Africa variant in South Africa, tested against the variant in Brazil. The Moderna and Pfizer vaccines weren't, we are not comparing t...