CDC: Anaphylaxis Rate With COVID Vax 10X That for Flu Shots, But Still Low

 While rare, the rate of anaphylaxis following COVID-19 mRNA vaccines appeared about 10 times that documented for flu shots, CDC officials said on Wednesday.

Overall, 21 cases of anaphylaxis following COVID vaccination were reported out of about 1.9 million doses given as of Dec. 23, according to an early Morbidity and Mortality Weekly Report release. That amounts to 11.1 cases per million versus an estimated 1.3 cases per million following inactivated influenza vaccine, agency officials said on a call with the media.

They noted that, as of now, 29 confirmed cases of anaphylaxis are reported with the Pfizer/BioNTech and Moderna vaccines. In addition, the officials said, the MMWR report from Dec. 14-23 focuses on the Pfizer vaccine, since the Moderna vaccine was not available until Dec. 21. Still, there is not enough data to see a difference in risk between vaccines.

No deaths from anaphylaxis have been seen to date.

Nancy Messonnier, MD, director of CDC's National Center for Immunization and Respiratory Diseases, emphasized that these events were rare and that the benefits of COVID-19 vaccination outweighed the risks. Moreover, comparing these to the numbers for flu "misses the point" when there are over 2,000 deaths from COVID-19 every day in the U.S.

"It's still a good value proposition," she said. "Even if the rate is higher than what we see after routine immunizations, anaphylaxis still remains rare."

Of the 21 cases reviewed in MMWR, 18 had documented allergies or allergic reactions to drugs, medical products, food, or insect stings, and seven had experienced anaphylaxis in the past, including one following a rabies vaccine and one following an influenza A (H1N1) vaccine.

Messonnier acknowledged the millions of people who have allergies to food or insect stings, and stressed the difference between "someone who had a mild allergic reaction in their childhood versus someone with a severe allergic reaction next week."

"A lot of people have some history of allergy to bee sting or food and the fact that people in this group had anaphylaxis ... may not mean allergic reactions put them at higher risk, but it might," she added.

Messonnier noted that CDC guidance indicates that anyone with a history of anaphylaxis for any reason should talk to their healthcare provider prior to vaccination and clinicians should exercise their judgment.

CDC officials said anyone with a history of anaphylaxis who gets the vaccine should be observed for 30 minutes afterwards, as people who previously had anaphylaxis are at risk of having it again.

The agency recently updated its interim guidance for clinicians about contraindications to the vaccine, adding that those with an immediate allergic reaction to the first vaccine should not receive a second dose.

Seventeen of the 21 cases were among those with a history of anaphylaxis, and median time from vaccination to symptom onset was 13 minutes, although around 70% of patients had symptom onset within 15 minutes. The median age of patients was 40, and 19 were women.

The MMWR report noted that female predominance had been seen earlier for immediate hypersensitivity reactions to influenza A (H1N1) vaccine. But the disproportion with COVID vaccination could simply be due to more women than men receiving the Pfizer/BioNTech vaccine, the authors said.

Nineteen patients were treated with epinephrine, 17 were treated in the emergency department, and four were hospitalized, including three in intensive care. Among 20 with available information, all were discharged home.

Also, Messonnier briefly addressed reports of healthcare workers electing not to get vaccinated, saying she was "definitely concerned" about it.

"It makes it exceedingly important that we get the correct information to healthcare workers and we quickly dispense with misinformation," she said. "We need them not only to protect themselves, but to educate their patients so everyone understands these vaccines ... have a good safety profile, they are working, and they ... can help us end this pandemic."

Primary Source

Morbidity and Mortality Weekly Report

Source Reference: CDC COVID-19 Response Team, FDA "Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine -- United States, December 14–23, 2020" MMWR 2021; Published Jan. 6, 2020.

https://www.medpagetoday.com/infectiousdisease/covid19/90556

HHS: States can vaccinate lower-priority groups if doses would go unused

 Secretary of Health and Human Services Alex Azar said Wednesday that he is advising states to begin vaccinating lower-priority groups against Covid-19 if the doses they have on hand would otherwise be sitting in freezers.

“It would be much better to move quickly and end up vaccinating some lower-priority people than to let vaccines sit around while states try to micromanage this process,” Azar said in a briefing, expressing frustration about the pace of vaccinations.

“Faster administration could save lives right now, which means we cannot let the perfect be the enemy of the good,” he said.

The comments indicate that states will have the Trump administration’s blessing to diverge from national guidance about vaccination priorities, and that they shouldn’t worry too much if hospitals or health care providers use doses out of order.

About 17.3 million vaccine doses have been distributed to states, while 5.3 million people have received an initial dose, according to the Centers for Disease Control and Prevention.

Azar offered Florida as an example of a state that had adjusted criteria for who’s eligible to receive a vaccine dose, so that the limited supply reaches people who need it. Azar said he had spoken by phone earlier Wednesday with Florida Gov. Ron DeSantis, a Republican.

DeSantis said two weeks ago that he would make Covid-19 vaccines available to people age 65 and older, putting them ahead of others who are younger but have jobs that put them at risk. The decision has caused chaos and some disappointment especially among people who haven’t procured appointments.

Florida ranks only in the middle of the pack so far for vaccinations as a share of its population.

There’s been debate nationwide about who should get priority for vaccinations. Though the CDC released guidelines, it’s ultimately up to states to determine people’s place in line — and how strictly to enforce the order.

New Jersey Health Commissioner Judith Persichilli said Wednesday that her state would not be rigid as it moves through different priority groups.

“It is not necessary to vaccinate all individuals in one phase before initiating the next phase,” she said during a briefing.

“The phases may in fact overlap,” she added. “The movement between phases will be very fluid. One phase will overlap with another. We will not wait for all individuals in one phase to be vaccinated before opening up to additional groups.”

https://www.nbcnews.com/health/health-news/hhs-states-can-vaccinate-lower-priority-groups-if-doses-would-n1253139

CVS, Walgreens to finish first round of Covid vaccines in nursing homes by Jan 25

 CVS Health and Walgreens said Wednesday they are on track to complete the first round of Covid vaccine shots at nursing homes across the country by Jan. 25.

The federal government partnered with the two pharmacy chains to administer the shots to residents and staff in long-term care facilities.

Nursing homes and assisted living facilities are at the top of the priority list for the vaccine, along with health-care workers. Vaccinations at the facilities mark one of the first major steps in the wider national rollout. Public health and state officials have prioritized the long-term care facilities because they have been especially hard-hit by coronavirus outbreaks and deaths. Less than 1% of the U.S. population lives in long-term care facilities, but they account for about 38% of all Covid-19 deaths in the country as of Dec. 31, according to COVID Tracking Project, an effort led by The Atlantic magazine.

With their updates this week, the companies offered a bright spot for a vaccine rollout that has been slower than federal officials and public health officials anticipated. The U.S. has distributed just over 17 million doses, and 4.8 million people have been given their first shot as of Tuesday — far short of the country’s original goal of immunizing at least 20 million people by the end of 2020.

CVS and Walgreens began inoculations at long-term care facilities in a few states on Dec. 18. They’ve since expanded to thousands of facilities across 49 states, the District of Columbia and Puerto Rico. West Virginia has not opted in to the federal program for Covid vaccinations at long-term care facilities.

CVS said it has confronted a couple of challenges during the program. The actual number of residents in nursing homes was about 20% to 30% lower than projections based on bed count, the company said in a news release. And it noted that “initial uptake among staff is low,” adding that part of that is likely due to facilities wanting to stagger vaccinations of staff. Facilities are spacing out employee vaccinations to avoid staffing shortages in case side effects keep some workers at home for a couple of days.

“We’re dealing with a vulnerable population that requires onsite and, in some cases, in-room visits at facilities with fewer than 100 residents on average,” CEO Larry Merlo said in a statement. “Despite these challenges we remain on schedule, and the number of vaccines we administer will continue to rise as more facilities are activated by the states.”

While more than 3.2 million doses of vaccine have been distributed by the federal government through the federal pharmacy partnership for long-term care program, just 429,000 have been administered as of Tuesday, according to data from the Centers for Disease Control and Prevention. But CVS noted that the CDC’s data lags reality by two to three days, which CDC acknowledges.

In the coming weeks, Dr. Nancy Messonnier, the director of the CDC’s National Center for Immunization and Respiratory Diseases, said Tuesday at an event hosted by STAT News that she expects the wider rollout of the vaccine to speed up.

“I really expect the pace of administration to go up pretty massively in the next couple weeks,” she said, adding that facilities are working out early kinks and getting comfortable handling the vaccines.

CVS, Walgreens and other drugstores and grocers have partnered with the Department of Health and Human Resources to offer vaccinations to the general public, when they’re available.

Walgreens said Wednesday that it’s working with states as they finalize plans for the next phase of the vaccine rollout, such as administering the shots to other high-priority groups like essential workers and people ages 75 and older.

CVS said Wednesday it’s in talks with several states “to make a limited number of doses available in the coming weeks in advance of the broader rollout.”

https://www.cnbc.com/2021/01/06/cvs-says-it-expects-to-finish-first-round-of-covid-vaccines-in-nursing-homes-by-jan-25.html

White House task force pushes for states to give COVID vax to whoever wants it

 Senior officials working with the White House coronavirus task force are pushing for states to start giving out the COVID-19 vaccine to whoever wants it, The Daily Beast reports.

• Specifically, the states would give out excess COVID-19 vaccines to whoever wants to get it.
• Officials said the move would end the strategy and debate about who gets the vaccine first. Rather, first-come, first-served would make sure vaccines don’t expire, and it would give people the vaccine more quickly, The Daily Beast reports.

So far, more than 4.2 million people have received the COVID-19 vaccine, but experts caution that number is far from where the U.S. needs to be at right now, as I wrote about for the Deseret News. Numbers could be lagging due to reporting issues.

Dr. Anthony Fauci said that number may grow soon. He told NBC there were 1.5 million vaccine doses distributed in 72 hours. That’s about 500,000 per day. So the numbers will climb.

How to make it work

Dr. Scott Gottlieb, former FDA chief, called on major pharmacies to start distributing the vaccine now in order to get it to more people, as I wrote about for the Deseret News

• “Make the vaccine more generally available through the retail pharmacies, through Walmart and Walgreens and CVS to a broader population, to a general population starting with age,” Gottlieb said in an interview on the “Face the Nation” program. “We can walk it down the age continuum, make it available for 75 and above first, then 70 and above, and 65 and above. There’s 50 million Americans 65 and above, a large percentage of them probably want to be vaccinated. At some point, we need to allow supply to meet demand here and get the shots into the arms of the people who really want to get vaccinated and are going to go out and seek out the vaccination.”

https://www.deseret.com/2021/1/6/22216894/white-house-coronavirus-task-force-covid-19-vaccine

NHS patients to get life-saving COVID-19 treatments from existing drugs

 

• Patients in intensive care units across the UK are to receive potentially life-saving treatments for COVID-19
• Government ensures life-saving drugs will be available in NHS healthcare settings with immediate effect

Patients across the UK who are admitted to intensive care units due to COVID-19 are set to receive new life-saving treatments which can reduce the time spent in hospital by up to 10 days, the government has announced today (Thursday 7 January).

Results from the government-funded REMAP-CAP clinical trial published today showed tocilizumab and sarilumab reduced the relative risk of death by 24%, when administered to patients within 24 hours of entering intensive care.

Most of the data came from when the drugs were administered in addition to a corticosteroid, such as dexamethasone – also discovered through government-backed research through the RECOVERY clinical trial – which is already provided as standard of care to the NHS.

Patients receiving these drugs, typically used to treat rheumatoid arthritis, left intensive care between 7 to 10 days earlier on average. The rollout of these treatments could therefore contribute significantly towards reducing pressures on hospitals over the coming weeks and months.

Updated guidance will be issued tomorrow by the government and the NHS to trusts across the UK, encouraging them to use tocilizumab in their treatment of COVID-19 patients who are admitted to intensive care units, effective immediately.

Supplies of tocilizumab are already available in hospitals across the UK and clinicians will be able to treat all those admitted to intensive care units, potentially saving hundreds of lives. The department is working closely with Roche, who manufacture tocilizumab, to ensure treatments continue to be available to UK patients.

https://www.gov.uk/government/news/nhs-patients-to-receive-life-saving-covid-19-treatments-that-could-cut-hospital-time-by-10-days

South Africa Skips National Regulatory Approval to Secure Covid Vax

 South Africa will start rolling out Covid-19 vaccines without requiring local regulatory approval of the shots, a step that other low- and middle-income countries scrambling to inoculate their populations against the coronavirus are expected to follow.

South Africa's health ministry said the country will in January receive 1 million doses of the vaccine developed by the University of Oxford and AstraZeneca PLC from the Serum Institute of India, which has an agreement to manufacture and distribute the shots. A second shipment of 500,000 doses is expected for February. The vaccine requires two doses to reach its full effect.

Other countries across Subsaharan Africa and the developing world are likely to emulate South Africa's decision to bypass local regulators in an effort to expedite getting shots for at least some of their most-at-risk citizens. Some lack their own national drug-approval authorities and are expected to rely on certification from the World Health Organization for rolling out Covid-19 vaccines.

The shots South Africa has ordered from India will be given to health care workers, who have borne the brunt of a surge in new cases of Covid-19. Researchers believe that the new wave in infections has been exacerbated by a new, likely more transmissible variant of the coronavirus discovered in the country. In December alone, 5,000 health care workers tested positive for the disease, placing an additional burden on hospitals already struggling.

South Africa, a country of 60 million people, reported on Wednesday 21,832 fresh cases of Covid-19, its highest daily count, and 392 deaths. Nearly one-third of coronavirus tests are coming back positive -- an indication that the true number of infections is likely much higher -- and the South African Medical Research Council said it recorded nearly 7,000 excess deaths in the week of Christmas, most of them likely due to Covid-19.

Allowing the distribution of the Oxford-AstraZeneca vaccine without first registering it with the South African Health Products Regulatory Authority is an unusual step for the country, which has established procedures for certifying new drugs. It highlights the public pressure on the government for not moving faster to secure vaccines, as well as fears that some manufacturers were dragging their feet on applying for approval in South Africa.

A senior health-ministry official said Sunday that no vaccine maker had filed the final paperwork for approval in South Africa. During a news conference, Anban Pillay, a deputy director at the ministry, detailed how officials had "tried to persuade" U.S.-based Moderna Inc. to register its vaccine -- already approved in America and the European Union -- in South Africa. "It's clear they have no intention of filing a dossier with SAHPRA at this stage," he said.

A Moderna spokesman said the company didn't understand South African health officials to be requesting it to register its vaccine there. He said Moderna remained in productive talks with South Africa on supplying its vaccine to the country and when it could do so.

Dr. Pillay said Sunday that he expected Pfizer Inc., whose shots have also been approved in the U.S. and the EU, and Johnson & Johnson, whose vaccine has yet to be approved anywhere, to complete their applications for registration with SAHPRA by the end of the month.

The main reason for some vaccine makers' slow pace of requesting approval in less significant markets is a lack of available doses. Most makers of approved or promising Covid-19 vaccines have already sold all doses due to be manufactured this year to governments in rich countries.

Many poor countries have pinned their hopes on getting Covid-19 vaccines on a global initiative -- sponsored by richer nations and charitable organizations such as the Bill & Melinda Gates Foundation -- that is ordering doses in bulk. That initiative, called Covax, aims to supply vaccines to 20% of participating populations by the end of 2021.

The deal with the Serum Institute of India is South Africa's first bilateral agreement with a vaccine maker and comes after the company said previously that it would only start exporting doses in March or April. South Africa has also ordered vaccines for 10% of its population from the Covax initiative. As an upper-middle-income country, South Africa will have to pay for these vaccines itself.

On Thursday, South Africa's Health Minister Zweli Mkhize noted that the Oxford-AstraZeneca vaccine had already been approved in several countries, including the U.K. and India. "As part of expediting the regulatory process, SAHPRA is applying reliance on that regulatory work, " he said.

It is unclear whether the shots will be distributed before getting the results of a South African trial of the vaccine, which are expected in the coming weeks. That trial will show whether the shots are equally effective against the new Covid-19 variant spreading in the country.

Shabir Madhi, the chief investigator of the trial, said the variant -- which in laboratory tests appeared to be resistant to some of the antibodies the body employs to fight Covid-19 -- may make the vaccine less effective, without given details. Earlier trials in the U.K. and Brazil showed that the Oxford-AstraZenca vaccine was 62% effective in preventing symptomatic Covid-19.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/South-Africa-Skips-National-Regulatory-Approval-to-Secure-Covid-19-Vaccines-Update-32142808/

French authorities recommend delaying second vaccine shots

 French health authorities have recommended delaying the second doses of Pfizer and BioNTech’s vaccine, Health Minister Olivier Veran said on Thursday.

Veran told reporters that the second shot of the vaccine could be delayed to six weeks after the first instead of three as had been planned so far.

https://www.reuters.com/article/us-health-coronavirus-france-vaccine-del/french-authorities-recommend-delaying-second-vaccine-shots-minister-idUSKBN29C2MY