Vitamin D supplementation may safely reduce the overall risk for acute respiratory infection compared with placebo, but the risk reduction is small and the relevance of these findings to coronavirus disease 2019 (COVID-19) is unknown and requires additional investigation. This is according to research published in Lancet Diabetes Endocrinology.
Since the COVID-19 pandemic began, interest in the role of vitamin D in reducing acute respiratory infections has increased. Results of randomized controlled trials, though, have been heterogenous and variable, with some demonstrating protection and others reporting findings that are null. Results of a 2017 meta-analysis indicated the potential protective effect of vitamin D supplementation. Researchers sought to build on those results by conducting a new systematic review and meta-analysis of studies conducted since December 31, 2015.
The primary study outcome was the proportion of patients who had one or more acute respiratory infection (upper, lower, or location unclassified). Secondary outcomes included the proportion of participants who experienced one or more upper or lower respiratory infection, emergency department visit, hospitalization, or both for an acute respiratory infection, death due to acute respiratory infection or respiratory failure, antibiotic use, absence from school or work, serious adverse events, death, and potential adverse reactions to vitamin D.
The analysis included 46 studies representing 75,541 patients. Thirty-five studies compared the effects of vitamin D regimen with placebo, 5 compared higher- and lower-dose vitamin D with placebo groups, and 6 compared the effects of higher dose vitamin D with lower-dose vitamin D regimens.
Primary outcome data were obtained for 98.1% of 49,419 available participants.
In the 35 studies that measured baseline 25(OH)D concentrations, mean levels ranged from 18.9 to 90.9 nmol/L. Across studies, vitamin D was administered through variable routes, including oral dosing, weekly dosing, bolus dosing once every month to once every 3 months, and combination bolus and daily dosing.
A significantly lower proportion of participants who were taking vitamin D supplements had 1 or more acute respiratory infections compared with those taking placebos (61.3% vs 62.3%; odds ratio [OR], 0.92; 95% CI, 0.86-0.99). The heterogeneity effect for these data was moderate (I2=35.6%).
For secondary comparisons of high vs low dose vitamin D supplementation, no significant differences in the proportion of at least one acute respiratory infection was noted between participant groups (68.2% vs 64.6%; OR, 0.87; 95% CI, 0.73-1.04; I2=0.0%).
In order to investigate the reasons for the heterogeneity of the effect for the primary comparison (vitamin D vs placebo), researchers conducted an analysis stratified by 2 participant level factors (baseline 25(OH)D concentration and age) and 4 trial-level factors (dose, dose frequency, trial duration, and presence or absence of airway disease). Four of these factors—baseline 25(OH)D concentration, dose, dose frequency, and trial duration—were prespecified in study protocols and two—age and presence or absence of airway infections—were exploratory analyses.
Compared with placebo groups, there was no significant effect of vitamin D supplementation on the risk of having 1 or more acute respiratory infection in participants with baseline 25(OH)D concentrations of less than 25 nmol/L, 25 to 49.9 nmol/L, 50 to 74.9 nmol/L, or greater than 75 nmol/L (ORs, 0.81, 1.04, 0.88, 0.76, and 1.00, respectively).
A significant protective effect of vitamin D supplementation was seen on the risk for developing one or more acute respiratory infection compared with placebo, particularly in trials where vitamin D was given daily (OR 0.78) compared with weekly dosing or bolus dosing once a month or once every 3 months (ORs, 0.97 and 0.98).
Significant protective effects were also noted against the risk of having one or more acute respiratory infection vs placebo in trials that were not restricted only to participants with asthma or chronic obstructive pulmonary disease (COPD).
The meta-analysis for secondary outcomes included only the results of placebo-controlled trials. Without considering participant- or trial-level factors, vitamin D supplementation did not demonstrate a significant effect on the proportion of participants who experienced 1 or more upper or lower respiratory infection, used antibiotics to treat an infection, reported absence from school or work, or had been admitted to the hospital, or who went to the emergency department.
Study limitations include the analysis of aggregate trial-level, rather than individual participant-level data due to the need for results in the face of the COVID-19 pandemic, a lack of participant-level data on race, ethnicity, or obesity as potential effect-modifiers, and an inability to account for other factors that might influence the protective effect of supplementation.
“This updated meta-analysis…showed a significant overall protective effect of this intervention compared with a placebo control,” the researchers wrote. “In contrast to findings of our previous meta-analysis of individual participant-level data, we did not see a protective effect…among participants with the lowest baseline 25(OH)D concentrations.”
“The vitamin D dosing regimen of most benefit was daily and used standard doses (400-1000 IU) for up to 12 months. The relevance of these findings to COVID-19 is not known and requires further investigation,” they concluded.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Jolliffe DA, Camargo Jr CA, Sluyter JD, et al. Vitamin D supplementation to prevent acute respiratory infections: A systematic review and meta-analysis of aggregate data from randomized controlled trials. Published online March 30, 2021. Lancet Diabetes Endocrinol. doi: 10.1016/S2213-8587(21)00051-6.
This article originally appeared on Endocrinology Advisor
Celebrities Push For Vaccine Equity At ‘Vax Live’ Benefit Concert
A benefit concert leveraged major star power in a Saturday broadcast to address the latest obstacles to resolving the pandemic: vaccine inequity and vaccine hesitancy.
During Global Citizen’s “Vax Live: The Concert to Reunite the World,” politicians, celebrities and musicians pleaded with the public to get vaccinated and discouraged world leaders from stockpiling vaccine supplies, as the world faces stark gaps in access to COVID-19 vaccines.
The event — pre-taped at SoFi Stadium in Inglewood, Calif., before an in-person audience of 27,000 fully vaccinated health care and essential workers — painted a picture of what a post-pandemic world could look like if all were immunized against the coronavirus.
At the top of the show, in her first of two performances of the night, pop star Jennifer Lopez embraced her mother on stage during a rendition of “Sweet Caroline.”
“We’ve been away from our loved ones for too long, but we’re back,” Lopez said. “While it’s getting better for us, there are people all over the world — especially in Africa, India and in the Latin world — who still need our help and our vaccines.”
Hugh Evans, CEO of the anti-poverty organization Global Citizen that put on the event, said that mother-daughter moment was “the power of the vaccine at work.”
“They were both fully vaccinated and, therefore, you can hug your friends and family again,” he told NPR. “It’s those powerful things that we were working towards.”
Ahead of the broadcast, Global Citizen said its campaign had raised $302 million and secured over 26 million COVID-19 vaccine doses.
The money will go toward vaccine delivery, testing and personal protective equipment, as part of the COVAX initiative. The effort, led by the World Health Organization, Gavi and other partners, aims to evenly distribute vaccines and supplies around the world.
Evans said all of the vaccine doses pledged will be delivered to low-income countries by the end of this year per an agreement with Gavi, the Vaccine Alliance.
Prince Harry, who co-chaired the event with his wife Megan Markle, took the stage to thank frontline workers.
“We cannot rest or truly recover until there is fair distribution to every corner of the world,” said the Duke of Sussex. “The virus does not respect borders and access to the vaccine cannot be determined by geography.”
“We must look beyond ourselves with empathy and compassion for those we know, and those we don’t.”
While the U.S. and other wealthy countries have more doses than people who want them, the poorest ones have gotten less than 1% of the global supply.
India is facing a severe second wave and just 2% of its population is fully vaccinated. And two dozen countries, mostly in Africa, are using less than a third of their vaccines due to distrust over perceived risks and a lack of international support to help cover vaccine delivery.
The event also saw video messages from Pope Francis, President Joe Biden and first lady Jill Biden and Vice President Kamala Harris.
His Holiness called for “a spirit of justice that mobilizes us to ensure true universal access to vaccines” and “a spirit of communion that allows us to generate a different economic model that is inclusive, just and sustainable.”
The president and first lady encouraged people to get vaccinated: “We can’t let up now,” President Biden said. “The vaccines are safe, I promise you, they’re safe. They work.”
In a snappy narrated clip, Oprah Winfrey unpacked the science of vaccines and rollout logistics with the help of public health experts.
Meghan Markle spoke about how women worldwide, especially women of color, “have seen a generation of economic gain wiped out,” due to the pandemic, with millions facing extreme poverty.
Selena Gomez, who hosted the concert special, sent an urgent plea to viewers.
“If you’re on the fence about getting vaccinated, if you don’t think you need it to protect yourself, I’m not going to lecture you. I’m going to beg you. Please get vaccinated — for your family, your neighbors, and every single person you come in contact with,” the singer said.
Also appearing on stage were Chrissy Teigen, David Letterman, Ben Affleck, Jimmy Kimmel, Sean Penn and Olivia Munn.
Musical acts included the Foo Fighters — with a surprise guest AC/DC’s Brian Johnson — along with Eddie Vedder, J Balvin and H.E.R.
Getting Women Back To Work Is Key To A Strong Recovery, Labor Secretary Says
The road to full economic recovery from the pandemic may be steeper than anticipated.
U.S. employers added 266,000 jobs last month, the Labor Department reported Friday. That’s far fewer than the nearly 1 million analysts expected given other recent signs of recovery: business reopening, consumer spending increasing, and new unemployment claims falling.
“Our economy is definitely recovering, but there are still millions of people in economic pain,” Labor Secretary Marty Walsh said in an interview with All Things Considered. “We still have issues around child care. We still have issues around vaccines. We still have issues around people getting the virus. So we still have a ways to go here.”
Child care problems and many kids still learning from home in part led millions of women to leave the workforce during the pandemic. Walsh said that’s a big concern for the Biden administration. The president’s proposed American Families Plan includes $225 billion for child care.
“We need to make sure if we’re going to have a strong recovery — a strong, equitable recovery — we need to get women back into the workforce,” Walsh said.
Following are highlights of the interview, edited for length and clarity.
On April’s weaker-than-expected jobs numbers
Under normal circumstances, adding 266,000 jobs to the economy is a good number, but obviously we’re not in normal times. We’re definitely seeing the economy go in the right direction, but we still have a steep hill to climb. If you look at over the last three months, however, we’ve averaged over 500,000 jobs on average over the last three months, so we’ve added 1.5 million jobs. That shows good gain there as compared to the previous three months.
On what’s holding employers back from adding more jobs
There’s no question about it. People are still recovering from the pandemic. There are still concerns as far as businesses. … There’s a bunch of bright sides of this report, but one of them was that we saw the leisure and hospitality industry grew immensely, and that includes restaurants. We also saw more people in the month of April looking for employment than the previous months. But we’re still in the midst of a pandemic.
On whether he’s concerned that this could be a jobless recovery
No, I don’t believe that. People are going to go back to work and people are going to get back to work. … The president has made it very clear with the American Rescue Plan about strengthening and getting this economy moving forward. … We are definitely moving in the right direction. Hospitality is opening in the different areas. We saw an increase in retail as well — in-person retail. But there’s still lots of lots of people still working from home or looking for employment.
On whether unemployment benefits discourage people from looking for work
You know, I don’t like when people talk about generous unemployment benefits because unemployment benefits are there to help people in very difficult, bad times. And many, many Americans have gone through very difficult, bad times for the last year. I think what we’re seeing is that there are still major barriers to getting people back into the workforce … lack of child care, also schools, you know, hybrid learning — in-person learning and online learning. People worried about the virus, people [worried] about getting vaccinated, people that are caretakers. So there’s still barriers there. I’m not saying that’s the whole excuse. … People want to be back in the workplace. People want to be back working. … With unemployment benefits, you don’t get health care. You don’t build your pension up. You don’t build all of those programs that you need to move forward.
On helping women get back into the workforce
A couple weeks ago, the president and the White House released $30 billion … to deal with that specific issue of child care. And it’s about making investments in the child care facilities around our country. And that money is getting out around the country right now. So that’s one one aspect. … We need to make sure if we’re going to have a strong recovery — a strong, equitable recovery — we need to get women back into the workforce.
And that’s something that the president is focused on. That’s something that I’m focused on here at the Department of Labor, as well as our unemployment numbers in the Black community. Today it is 9.7%. So our communities of color have higher unemployment rates than their white counterparts. … We’ve always seen that discrepancy going back generations. But we have to be really intentional about investments that we’re making to make sure that as we recover from the pandemic, it’s an equitable recovery for all — for women and for people of color.
Robert Baldwin III and William Troop produced and edited the audio version of this story. Avie Schneider produced for the web.
Ramping Up Its COVID Response, EU Will Buy Up To 1.8B Doses Of Pfizer Vaccine
The European Union and Pfizer-BioNTech have signed a deal for up to 1.8 billion doses of the COVID-19 vaccine. The bloc’s biggest contract to date would cover its entire population, marking a significant ramp up in its fight against the coronavirus.
EU Commission President Ursula von der Leyen announced the deal in a tweet, writing it is for a ” for guaranteed 900 million doses (+900 million options).”
Other contracts and other vaccine technologies will follow.
— Ursula von der Leyen (@vonderleyen) May 8, 2021
Von der Leyen says other contracts and vaccines are coming for the 27-member bloc with a population of around 450 million.
The enormous Pfizer-BioNTech contract for the two-dose shot would help cover future unknowns including whether a booster shot will be required and what will happen with circulating variants.
The agreement calls for vaccine production to happen within the EU. Delivery will likely extend into 2023.
Last month, the commission announced 250 million Pfizer-BioNTech doses would be delivered by June. The EU’s executive arm approved use of the vaccine late last year after the European Medicines Agency, gave its authorization.
But the virus is still spreading. France, Italy and Spain are currently reporting the most COVID-19 cases. In its bid to contain transmission, the EU is aiming to get 70% of adults vaccinated.
The Pfizer-BioNTech deal underscores confidence in the vaccine. For its part, the Oxford-AstraZeneca vaccine has had halting rollout in the EU, with delivery delays and warnings about rare blood clots occurring in some recipients.
In the U.S., approximately 170 million Pfizer-BioNTech vaccines have been delivered, according to the Centers for Disease Control and Prevention, with nearly 140 million shots administered. Three vaccines are authorized for emergency use and nearly 60% of the adult population has gotten at least one shot.
The Pfizer-BioNTech vaccine was the first approved in the U.S. in December when federal officials granted emergency use authorization.
Now the U.S.-based Pfizer and its German partner BioNTech are requesting full approval in the U.S. for people 16 and older, a process that involves more rigorous oversight, including providing follow-up data six months after vaccinations.
The vaccine maker is also seeking emergency use authorization in the U.S. to include children 12 to 15 years old.
Reporter Teri Schultz contributed to this report from Brussels.
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Pfizer Seeks Full FDA Approval For COVID-19 Vaccine
Pfizer and its vaccine partner BioNTech have started an application to request the Food and Drug Administration’s approval for its COVID-19 vaccine.
Pfizer is the first coronavirus vaccine maker in the U.S. to request full approval. Like Pfizer, the Moderna and Johnson & Johnson vaccines had been previously cleared for use under the agency’s emergency use authorization — a less rigorous approval method to aid a swifter response to the pandemic.
An FDA approval for a vaccine means the agency has decided that its benefits outweigh the known risks following a review of the manufacturer’s testing results.
If granted, Pfizer’s full stamp of approval would only apply to the vaccine for people who are 16 and older. Meanwhile, the vaccine maker is seeking emergency use authorization for its COVID-19 vaccine to include children between 12 and 15.
“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” Pfizer CEO Albert Bourla said in a press release Friday.
BioNTech’s CEO, Dr. Ugur Sahin, called the submission of the application for FDA approval “an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”
“We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”
In that final phase of clinical trials, Pfizer found that its vaccine was 95% effective against COVID-19, the highest efficacy among vaccines authorized for emergency use in the United States.
For the FDA to grant approval, Pfizer-BioNTech will have to comply with a key requirement: providing follow-up data six months after vaccinations.
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