Covid-19 vaccine no 'walk in the park'

The people of America need to know and be prepared for the possibility that they may feel a little unwell after they get a coronavirus vaccine, if one is authorized, according to the members of a US Centers for Disease Control and Prevention advisory committee.

The CDC's Advisory Committee on Immunization Practices met to discuss whether to recommend use of any Covid-19 vaccine that the US Food and Drug Administration might authorize on Monday, CNN reported.

Volunteers in vaccine trials have reported they frequently feel flu-like effects after getting vaccinated, and representatives who took part in the discussion -- said that could affect people's willingness to get vaccinated in the first place, or to get the second dose of the two-vaccine regimen.

"As a practicing physician, I have got to be sure my patients will come back for the second dose. We really have got to make patients aware that this is not going to be a walk in the park," Dr Sandra Fryhofer of the Emory University School of Medicine, representing the American Medical Association, told the meeting.

"They are going to know they got a vaccine. They are not going to feel wonderful."

The whole point of vaccination is to cause an immune response in the body and that can sometimes cause flu-like symptoms such as body aches, or even fever and a headache.

Patricia Stinchfield of Children's Hospitals and Clinics of Minnesota, representing the National Association of Pediatric Nurse Practitioners, said providers must be ready to explain this to people getting any vaccine.

"These are immune responses, so if you feel something after vaccination, you should expect to feel that. And when you do, it's normal that you have some arm soreness or some fatigue or some body aches or even some fever," Stinchfield told the meeting. Some people may feel bad enough to need to stay home from work for a day, she said.

Dr Paul Hunter of the city of Milwaukee health department and a voting member of the committee, said it will be important for the first people to get vaccinated to describe these experiences to others.

Boosting Confidence

"The people who highly value getting the vaccine soon and fast, early, are going to be really helpful to everyone else. And I think we really are going to need to honor them, because they are going to let us know how it feels," he said. "And I think these people are likely to be health care workers who are likely to be up for that kind of task."

Public willingness to get a coronavirus vaccine has been steadily dropping since the spring, but it might improve when people start to hear more about the safety and efficacy of the various vaccines in the works, the CDC's Dr Sara Oliver told the committee during the five-hour-long meeting.

Oliver said the CDC has been looking at various surveys on attitudes and noted that anywhere between 40% and 80% of those surveyed said they'd be willing to get vaccinated.

"Many adults reported intentions to receive Covid vaccine. But concerns were raised around side-effects, unknown efficacy and the speed of the (authorization) process," Oliver told the meeting.

Vaccine acceptance was highest among Asian-Americans and lowest among African-Americans, Oliver said. That's of concern because ACIP wants to make sure any vaccine that is approved gets to the groups most affected by the pandemic, and Blacks are among the hardest hit by Covid-19.

Nurses were also a concern. One survey showed that while nurses agreed vaccines were likely to be safe and effective, only 34% would voluntarily get vaccinated, Oliver said.

Members of ACIP said they thought these fears could be addressed with education campaigns and as people learned about data showing that, for example, the Pfizer and Moderna vaccines were about 95% effective in preventing symptomatic disease with no significant safety concerns.

Vaccine Allocation

Any plan for distributing coronavirus vaccine should take into account fair and equitable access to everyone—especially groups that are disproportionately affected by the pandemic.

Fair access is at the top of the list, ACIP committee members said in a document published at the start of the meeting.

"How do characteristics of the vaccine and logistical considerations affect fair access for all persons?" they asked in the document, released in the CDC's MMWR report.

"Does allocation planning include input from groups who are disproportionately affected by Covid-19 or face health inequities resulting from social determinants of health, such as income and health care access?"

The CDC, the National Academies of Science, Engineering and Medicine and other advisers have proposed four groups that should get vaccinated first: health care personnel, other essential workers, adults with high risk medical conditions and other adults 65 and older.

That's a lot of people. The CDC estimates there are 21 million healthcare personnel, 87 million essential workers, 100 million adults with high risk medical conditions and 53 million others are 65 and older. The federal government has said 40 million coronavirus vaccine doses could be available by the end of December.

There's little disagreement that frontline healthcare workers should be in the first group -- designated as 1a. At issue is whether residents of long term care facilities should be in this group, also.

There's no question it's a highly vulnerable population. "Long term care facility residents and staff accounted for 6% of cases and 39% of deaths in the US, despite the fact that long term care facility residents account for less than 1% of the US population," the CDC's Dr Kathleen Dooling told the meeting.

Plus, it's a group that would be easier to reach if the staff caring for them are already being immunized in the first phase of any vaccine that might get emergency authorization from the FDA.

But ACIP member Dr Helen Keipp Talbot worried that this frail group might do poorly in general and damage faith in the vaccine.

"There is such a high mortality rate in long term care facilities," Talbot told the meeting. "There will be a number of patients who receive immunizations for Covid and will pass away. And it will be regardless of the vaccine and most likely will be regardless of the vaccine," Talbot said.

"But early on as we're building confidence and we will not be able to show any data to say that it was not due to the vaccine because there's not been a randomized, controlled trial. And I think we're going to have a very striking backlash of 'my grandmother got the vaccine and she passed away,' and they're not likely to be related, but that will become remembered and break some of the confidence in the vaccine."

But others did not think that putting these residents further back in line would help.

Hunter said it would be inefficient to vaccinate healthcare workers in the facilities but skip residents. "Why not vaccinate people that, you know, you, you've got it all set up and ready to go?" he asked. "It's an efficiency to vaccinate a bunch of people who could benefit from it."

The ACIP will not make a decision Monday. The group will meet after the FDA's Vaccine and Related Biological Products Advisory Committee (VRPBAC) meets Dec. 10 to discuss an application by vaccine maker Pfizer and its German partner BioNTech for an emergency use authorization.