Friday, April 2, 2021 | Kaiser Health News

Reuters:
Moderna Gets Nod To Speed Up Virus Vaccine Output With Bigger Vials

The U.S. drug regulator gave Moderna Inc clearance to speed up output of its COVID-19 vaccine by letting it fill a single vial with up to 15 doses, with the United States banking on rapid immunisation to stem the spread of the deadly virus. The U.S. Food and Drug Administration (FDA) also authorized vaccinators to extract a maximum of 11 doses from the current vials, instead of the ten previously permitted. In a statement, Moderna said its vaccine can now can be supplied in vials containing 11 or 15 doses, and it expected to begin shipping 15-dose vials in coming weeks. (4/2)

Politico:
FDA Allows Moderna To Put More Coronavirus Vaccine Doses In Each Vial

The agency also gave permission to vaccinators to extract 11 doses from existing 10-dose vials vials, depending on the availability of certain syringes and needles. Some pharmacies have already said that they have been able to eke extra doses from existing vials. “Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly,” FDA vaccine regulator Peter Marks said in a statement. “Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly.” (Lim, 4/1)

AP:
The Latest: FDA Authorizes 2 Changes To Moderna’s Vaccine

The U.S. Food and Drug Administration has authorized two changes to Moderna’s COVID-19 vaccine that can provide extra doses from each vial. The agency said late Thursday it approved new vials from Moderna that can contain up to 15 doses each, compared with the original vials designed to hold 10 doses. Additionally, regulators said providers can safely extract up to 11 doses from the original 10-dose vials. Those changes will be added to instructions for health care workers. The dosing updates should help bolster U.S. supplies and speed vaccinations as the U.S. nears 100 million inoculations against COVID-19. President Joe Biden has vowed to provide enough shots to vaccinate all U.S. adults by late May and recently set a new goal of administering 200 million injections within his first 100 days in office. (4/2)

The Wall Street Journal:
FDA Probes Cause Of Failed Johnson & Johnson Covid-19 Vaccine Batch

The Food and Drug Administration is investigating what caused a batch of the active ingredient for Johnson & Johnson’s Covid-19 vaccine to be scrapped for failing to meet quality standards at a contract manufacturing plant, according to a person familiar with the matter. The FDA may send an inspection team to assess the situation at the Baltimore plant operated by contractor Emergent BioSolutions Inc., the person said. The regulatory scrutiny follows J&J’s disclosure Wednesday that a batch of the main ingredient for its Covid-19 vaccine manufactured at the Emergent plant didn’t meet standards. The batch didn’t reach the vial-filling and finishing stage, and no doses from it were distributed. (Loftus and Burton, 4/1)

AP:
Company Producing J&J Vaccine Had History Of Violations

The company at the center of quality problems that led Johnson & Johnson to discard 15 million doses of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.Emergent BioSolutions, a little-known company vital to the vaccine supply chain, was a key to Johnson & Johnson’s plan to deliver 100 million doses of its single-shot vaccine to the United States by the end of May. But the Food and Drug Administration repeatedly has cited Emergent for problems such as poorly trained employees, cracked vials and problems managing mold and other contamination around one of its facilities, according to records obtained by The Associated Press through the Freedom of Information Act. The records cover inspections at Emergent facilities since 2017. (Lardner, Dearen and Johnson, 4/1)

The Washington Post:
FDA Found Violations At Emergent Plant That Ruined Johnson And Johnson Vaccine Doses

In April last year, an investigator from the Food and Drug Administration reported problems he had discovered at a Baltimore plant operated by Emergent BioSolutions, a major supplier of vaccines to the federal government. Some employees had not been properly trained. Records were not adequately secured. Established testing procedures were not being followed. And a measure intended to “prevent contamination or mix-ups” was found to be deficient. (Swaine and Rowland, 4/2)

Stat:
Federal Agency Urges FDA To Rethink Approach To Inspection Oversight

In a stern letter, the U.S. Office of Special Counsel rebuked the Food and Drug Administration over four instances in which agency officials belatedly downgraded troubling findings at manufacturing plants and also urged the FDA to rethink its approach to oversight of inspections. The investigating agency cited, in particular, a high-profile episode involving a Merck (MRK) vaccine plant in North Carolina, where a whistleblower tipped off the FDA to numerous sanitary problems. An FDA inspector who subsequently visited the plant maintained the violations were serious enough to warrant action by both the FDA and the drug maker. But his recommendations were minimized by supervisors. (Silverman, 4/1)

Politico:
Emergent Admits To Manufacturing Issues With J&J Vaccine

A contractor Johnson & Johnson enlisted to make its coronavirus vaccine acknowledged Thursday that it had contaminated millions of doses, confirming reports of supply problems related to the firm’s Maryland facility. The acknowledgment by Emergent BioSolutions came one day after news reports revealed the mistake at its West Baltimore plant that affected 15 million doses. The company signed on to produce a J&J vaccine substance last spring and later added AstraZeneca, another drugmaker producing a potential Covid-19 shot, to its roster of clients. Emergent previously promised to deliver 1 billion shots between the two by the end of this year. (Owermohle, 4/1)

The Baltimore Sun:
Mistakes Happen, But The One Made By A Baltimore COVID Vaccine Maker May Hurt For A While 

When an East Baltimore plant run by Emergent BioSolutions found that a large batch of urgently needed COVID-19 vaccine had to be trashed because workers used the wrong ingredients, the company said the episode was “disappointing” but showed that its rigorous quality controls worked. That’s true, say vaccine supply chain and public health experts. Snafus are not infrequent in plants producing complex vaccines and therapeutics, and the pandemic likely added to the pressure to produce. (Cohn, 4/2)

The Wall Street Journal:
Pfizer’s Covid-19 Vaccine Is Still Highly Effective Six Months After Second Dose

The Covid-19 vaccine from Pfizer Inc. and BioNTech SE remains highly effective six months after its second dose, an indication that protection could last for an even longer period. The findings, released on Thursday, emerged from a continuing review of how volunteers in the shot’s late-stage trial were faring and whether they contracted Covid-19 with symptoms. In the rush to introduce vaccines for a new virus, companies and other vaccine researchers were unable to determine how long shots would provide protection, or whether booster shots would be needed to ensure protection. (Hopkins, 4/1)

Axios:
Pfizer Says COVID-19 Vaccine 91.3% Effective Through At Least 6 Months 

Real-world and trial data continue to indicate that the vaccine is highly effective, especially against COVID-19 hospitalization and death. The companies said updated trial results showed the vaccine offered 100% protection against severe disease as defined by the CDC, and 95.3% as defined by the FDA. 927 symptomatic COVID-19 cases were detected among the trial’s 46,307 participants — 850 of which came from the placebo group and 77 of which came from the vaccine group. (4/1)

Vox:
Moderna Vs Pfizer Vaccine: Why You Shouldn’t Decide Which Is Better Based On Efficacy

n the US, the first two available Covid-19 vaccines were those from Pfizer/BioNTech and Moderna. Both vaccines have very high “efficacy rates” of around 95 percent. But the third vaccine introduced in the US, from Johnson & Johnson, has a much lower efficacy rate: just 66 percent. Look at those numbers next to each other, and it’s natural to conclude that one of them is considerably worse. Why settle for 66 percent when you can have 95 percent? But that isn’t the right way to understand a vaccine’s efficacy rate, or to even understand what a vaccine does. And public health experts say that if you really want to know which vaccine is the best one, efficacy isn’t actually the most important number at all. (Marshall and Mas, 4/1)

More on the vaccines developed by AstraZeneca and NovaVax —

Reuters:
Exclusive: Fauci Says U.S. May Not Need AstraZeneca COVID-19 Vaccine

The United States may not need AstraZeneca’s COVID-19 vaccine, even if it wins U.S. regulatory approval, Anthony Fauci, the nation’s top infectious disease doctor told Reuters on Thursday. The vaccine, once hailed as another milestone in the fight against the COVID-19 pandemic, has been dogged by questions since late last year, even as it has been authorized for use by dozens of countries, not including United States. Fauci, director of the National Institute of Allergy and Infectious Diseases and chief medical adviser to the White House, said the United States has enough contracts with other vaccine makers to vaccinate its entire population, and possibly enough for booster shots in the fall. (Steenhuysen, 4/2)

Reuters:
UK Regulator Found Total Of 30 Cases Of Blood Clot Events After AstraZeneca Vaccine Use

British regulators on Thursday said they have identified 30 cases of rare blood clot events after the use of the AstraZeneca COVID-19 vaccine, 25 more than the agency previously reported. The Medicines and Healthcare products Regulatory Agency said it had received no such reports of clotting events following use of the vaccine made by BioNTech SE and Pfizer Inc. (4/2)

CNN:
How The Novavax Covid-19 Vaccine Works 

At the headquarters of biotechnology company Novavax, scientists are developing what they hope could soon be another Covid-19 vaccine for the United States and the world. Data from the company’s large-scale Phase 3 clinical trial of the vaccine in the US and Mexico are expected this month, but the timeline depends on how quickly it accumulates data on the prevalence of disease in trial areas. The company’s vaccine against Covid-19 has been a year in the making, Dr. Gregory Glenn, president of research and development for Novavax, told CNN. The work began even before the world realized it faced a pandemic. (Howard, 4/1)

The New York Times:
Biden Administration Announces Ad Campaign To Combat Vaccine Hesitancy

The Biden administration on Thursday morning announced an ambitious advertising campaign intended to encourage as many Americans as possible to be vaccinated against the coronavirus. The campaign, with ads in English and Spanish that will air throughout April on network TV and cable channels nationwide, as well as online, comes as the administration is rapidly expanding access to coronavirus vaccines but skepticism about the vaccines also remains high. (Karni, 4/1)

The Washington Post:
‘We Can Do This’: Biden Unveils Pro-Vaccine TV Ads, Network Of Grass-Roots Leaders To Push Shots

The Biden administration on Thursday unveiled its first television advertisements to encourage Americans to get vaccinated against the coronavirus, part of a series of pro-vaccine messages as the White House pushes to achieve the president’s goal of returning the country to some normalcy by July Fourth. The “We Can Do This” campaign will air across cable and broadcast stations nationwide and include targeted multimillion-dollar ad buys for Black and Spanish-language media. (Diamond, 4/1)

Stateline:
Just Half Of Long-Term Caretakers Are Vaccinated Against COVID 

Union leaders, facility owners and staff members who led by example, such as [Alice] Hakata, have been working to curb vaccine hesitancy of long-term caretakers nationwide, but only about half those workers have been vaccinated so far, according to Ruth Link-Gelles, an epidemiologist and member of the Centers for Disease Control and Prevention’s Vaccine Task Force. Vaccinating the remaining half of these frontline workers may fall only on states and the facilities themselves when a federal program to inoculate caretakers ends in the next few weeks. As of March 18, 1.86 million staff members at long-term care facilities nationwide had received at least one dose of a COVID-19 vaccine, according to CDC data, shared with Stateline. The numbers were reported by pharmacies that partnered with the agency to administer vaccines through the national Pharmacy Partnership for Long-Term Care Program. (Hernández, 4/1)

Other frequently asked vaccination questions —

CNN:
Wait To Be Fully Vaccinated Before Resuming Normal Activities, Health Experts Plead With Americans 

With fears growing that the US may be facing a fourth surge of Covid-19 cases, health experts are pleading with Americans to keep taking precautions until they are fully vaccinated. “Please wait until you’re fully vaccinated before you’re traveling, before you’re engaging in high-risk activities,” said CNN Medical Analyst Dr. Leana Wen. “No doubt when you become vaccinated, the activities that were once higher risk are now going to be lower risk and so just wait until then.” Wen said she worries the US is on the “precipice” of a fourth surge as data is showing that infections are now skewed toward a younger generation. (Holcombe, 4/2)

AP:
Can I Still Spread The Coronavirus After I’m Vaccinated?

Can I still spread the coronavirus after I’m vaccinated?It’s possible. Experts say the risk is low, but are still studying how well the shots blunt the spread of the virus. The current vaccines are highly effective at preventing people from getting seriously sick with COVID-19. But even if vaccinated people don’t get sick, they might still get infected without showing any symptoms. Experts think the vaccine would also curb the chances of those people spreading the virus. “A vaccinated person controls the virus better, so the chances of transmitting will be greatly reduced,” said Dr. Robert Gallo a virus expert at the University of Maryland School of Medicine. (Renault, 4/1)

San Francisco Chronicle:
How Long Will Your Coronavirus Vaccination Last? Here’s What We Know About Immunity So Far

More than three months into the rollout of coronavirus vaccinations in the U.S., many may already be wondering: How long will the protection last? The short answer is, we do not yet know for certain. Not enough time has passed to gather the research to determine a more exact estimate. The only definitive answer is that vaccine immunity will last at least three months, because that is how long vaccine trial participants were studied. But experts believe that immunity will last longer, with some convinced it could be years. (Hwang, 4/1)

CNBC:
Can I Be Forced To Get The Covid Vaccine

President Joe Biden said in March that the U.S. aims to have 200 million Covid vaccine doses administered during his first 100 days in office. By May, every American adult who wants a vaccine will be eligible to get in line for a shot. That said, 30% of U.S. adults still don’t want to get the Covid vaccine. But many of them may not have much of a choice. (4/1)

CNN:
Covid-19 Vaccine Side Effects: Why You Shouldn’t Freak Out Of These Happen To You 

With millions more Americans getting vaccinated every day, some have complained about fever, fatigue and other ailments they weren’t expecting. Don’t panic, doctors say. Side effects from Covid-19 vaccines won’t last long. And they’re actually proof that your immune system is working the way it’s supposed to. (Though vaccines are still very effective even without side effects.) (Yan, 4/1)

The Oregonian:
Ask A Pediatrician: Do Kids Really Need The Coronavirus Vaccine? 

A big question among parents and teachers as more schools reopen is when their kids will be vaccinated against COVID-19. Some have wondered whether the vaccine is even necessary for children. (4/1)

On the thorny issue of vaccine “passports” —

The Atlantic:
Social Distance: No Shirt. No Shoes. No Shots. No Service. 

Vaccine passports are almost certainly in our near future. But what are they exactly? And with concerns about vaccine equity now complicated by partisan fear mongering, how should they be implemented? Arthur Caplan, a bioethicist with NYU’s Grossman School of Medicine who’s spent years thinking about vaccine ethics, joins James Hamblin and Maeve Higgins on the podcast Social Distance to explain. Listen to their conversation here: (4/1)

Grow:
Why Not To Share Your Vaccination Card On Social Media

You might want to share online that you received your Covid-19 vaccine, but posting the CDC vaccination record card on social media can make you a target for identity theft. “It’s great that people are excited about getting vaccinated — it’s one step to getting back to normal,” says Sandra Guile, director of communications at the International Association of Better Business Bureaus. “What they’re doing is saying, ‘Hey, I got my first shot or my second shot.’ And they’re sharing their card online.” (4/1)

The Washington Post:
Vaccine passport apps are here. Without a common standard, tech challenges are myriad

Coming soon to your smartphone: Digital codes that afford you access to airplanes, concert venues and even restaurants. Vaccine passports are new apps that will carry pieces of your health information — most critically your coronavirus vaccination status. They may soon be required to travel internationally or even to enter some buildings. (Lerman, 4/2)

Stat:
Businesses, Health Experts Join Ranks Of ‘Vaccine Passport’ Opponents

When it comes to decrying the concept of “vaccine passports,” conservatives have company. The idea’s detractors now include certain business owners, who fear customer backlash and the hassle or danger of enforcing the policy, and even prominent public health advocates, too. The proof-of-vaccine concept is gaining traction in some circles globally and within the U.S., including among some professional sports teams, a major university, and highly vaccinated countries like Israel. In New York and Hawaii, among other states, governors have pitched the idea as a means of returning to normal life. (Facher, 4/1)

KHN:
Beating The Pavement To Vaccinate The Underrepresented — And Protect Everyone

Leonor Garcia held her clipboard close to her chest and rapped on the car window with her knuckles. The driver was in one of dozens of cars lined up on a quiet stretch of road in Adelanto, California, a small city near the southwestern edge of the Mojave Desert. He was waiting for the food bank line to start moving and lowered the passenger window just enough to hear what Garcia wanted. Then she launched into her pitch. “Good morning! We’re here to talk about covid-19 today! Do you have a minute?” she said in Spanish. (Almendrala, 4/2)