Moderna’s coronavirus vaccine faces U.S. FDA expert panel review

(Reuters) – A panel of outside advisers to the U.S. Food and Drug Administration is expected to endorse emergency use of Moderna Inc’s coronavirus vaccine during a meeting on Thursday, as the nation prepares to roll out a second vaccine.

The panel vote on whether the vaccine’s benefits outweigh its risks is likely to come some time after 3 pm ET (2000 GMT), with an FDA authorization expected as soon as Friday.

This is the same committee of expert advisers that last week backed the COVID-19 vaccine from Pfizer Inc and German partner BioNTech SE, clearing the way for the FDA emergency use authorization (EUA) a day later.

That vaccine is being distributed throughout the country. A massive inoculation program began at U.S. hospitals on Monday.

The Moderna vaccine uses similar messenger RNA technology but with less onerous cold storage requirements than the Pfizer/BioNTech shot, making it a better option for remote and rural areas. Both vaccines were about 95% effective in preventing illness in pivotal clinical trials.

The FDA advisory committee is likely to discuss Moderna’s reports of side effects from its 30,000-person trial, which were more frequent than those reported by Pfizer. These were primarily relatively short-lived reactions to the vaccination rather than serious adverse events.

SVB Leerink analysts said the Moderna vaccine appears less tolerable than the Pfizer/BioNTech shot, but noted that is not a proper comparison across trials and unlikely to stand in the way of an EUA.

The FDA staff did not raise any serious concerns about safety in documents published on Tuesday in preparation for the meeting. It said a link between Bell’s palsy, which causes temporary paralysis of facial muscles, and the vaccine could not be ruled out after some cases were reported in trials of both vaccines.

Pfizer and BioNTech said those cases occurred at the same rate as in the general population.

Moderna is seeking authorization for people aged 18 and older. That could sidestep the lively discussion last week among panel members about whether there was enough data to authorize use of the Pfizer/BioNTech vaccine in adolescents aged 16 and 17. They ultimately voted to back that vaccine for those 16 and older.

Initial Moderna vaccine supply would likely go to the United States, which has signed deals to secure as many as 200 million doses and is expecting the first 20 million this month. The vaccine is administered in two doses about four weeks apart.

The company has also signed supply deals with Canada, the European Union and the UK. The vaccine is undergoing a “rolling review” by regulators for all three.

(Reporting by Manas Mishra in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

U.S. employers could mandate a COVID-19 vaccine, but are unlikely to do so: experts

By Tina Bellon

(Reuters) – Private U.S. companies have the right under the law to require employees to get vaccinated against COVID-19, but are unlikely to do so because of the risks of legal and cultural backlash, experts said.

Companies are still in the early stages of navigating access and distribution of vaccines against the disease caused by the novel coronavirus, but inoculation is considered the key to safely resume operations at crowded warehouses, factory lines and on sales floors.

“Companies have every good reason to get all of their employees vaccinated and also have an obligation to keep all employees and customers safe,” said Lawrence Gostin, a global health law professor at Georgetown University.

Gostin and five other health law experts said private companies in the United States have broad liberties to set health and safety standards, which would allow them to mandate vaccinations as a condition of employment with some exceptions.

The Equal Employment Opportunity Commission in May said employers were allowed to compel employees to get a coronavirus test before allowing them to return to work, a decision that some experts said might be extended to vaccine mandates.

But Robert Field, a law and public health professor at Drexel University, said companies considering mandates should wait for vaccines to undergo a full-fledged regulatory review process.

“Employers are on shakier grounds because of the emergency use authorization,” Field said, adding there was no precedent for vaccine mandates during that phase.

U.S. courts that have ruled on lawsuits by healthcare workers opposing employer-mandated flu vaccines have largely sided with hospitals as long as they provided reasonable exemption policies, court records showed.

REGULATORY PATCHWORK

In Europe, companies face a patchwork of national vaccine regulation, with some countries mandating childhood vaccines, but European employers overall are unlikely to be able to mandate vaccination for staff, experts said.

In France, which in 2018 began mandating some childhood vaccines, some vaccinations are obligatory for professionals in the social and healthcare industry. President Emmanuel Macron has said a coronavirus vaccine will not be mandatory.

In Germany currently, only measles vaccines are mandatory for some employees and companies have no sufficient legal basis to order COVID-19 vaccination, said Pauline Moritz, a Frankfurt-based employment law attorney.

And in the UK, the government has no legal power to compel vaccination and employers attempting to mandate vaccines would likely confront human rights concerns, employment lawyers at Morgan Lewis wrote in a blog post.

U.S. agencies to date have not weighed in on COVID-19 vaccine mandates, but the Occupational Safety and Health Administration (OSHA) in the past has said employers have the right to mandate vaccines.

OSHA referred a request for comment to the U.S. Department of Health and Human Services, which did not respond.

VACCINE MANDATES UNLIKELY

U.S. companies so far are shying away from discussing vaccine mandates, ahead of formal approval for a vaccine by the U.S. Food and Drug Administration.

Ford Motor Co, which has ordered a dozen ultra-cold freezers to distribute vaccines to employees, said they would be made available on a voluntary basis.

A spokeswoman for Kellogg Co said the company was working with a medical expert and industry trade associations to make vaccines available to employees on a voluntary basis, in compliance with local and regional regulations.

“Companies could theoretically issue a mandate, but in the current political climate it is very unlikely they will do so,” said Peter Meyers, a law professor at George Washington University Law School. “Americans tend to shy away from mandates.”

Surveys have shown many Americans have safety concerns about a COVID vaccine, with nearly half of the 10,000 respondents polled in a September Pew research survey saying they would definitely or probably not get the vaccine.

Some experts said any vaccine mandates would prompt litigation. Cases alleging infringement on religious freedom could make it to a more conservative U.S. Supreme Court.

Vaccine mandates are common in the U.S. healthcare industry, where many hospitals require staff to take annual flu shots and all U.S. states mandate vaccines for school children.

Employees and parents can object to vaccines largely on two grounds: medical conditions that contraindicate vaccination or – depending on the U.S. state – religious or personal believes.

Some union contracts with individual employers, particularly in the healthcare industry, also prevent mandatory vaccines.

If an employee rejects vaccination on religious grounds, an employer has to make a reasonable effort to accommodate the worker, such as offering a transfer to a different department with fewer personal interactions or mandating masks, said Dorit Rubinstein Reiss, a law professor at UC Hastings.

So far two companies, Pfizer Inc and Moderna Inc, have asked the U.S. Food and Drug Administration for emergency use authorization of their vaccine candidates.

The chief adviser of the U.S. government’s COVID-19 vaccine program said on Tuesday that 20 million people could be vaccinated by the end of 2020, and that by the middle of 2021 most Americans will have access to highly effective vaccines.

(Reporting by Tina Bellon in New York; Additional reporting by Richa Naidu in Chicago; Editing by Joe White and Nick Zieminski)

It’s not for me: speed of COVID-19 vaccine race raises safety concerns

By Francesco Guarascio and Josephine Mason

BRUSSELS/LONDON (Reuters) – The frenetic race to develop a COVID-19 vaccine has intensified safety concerns about an inoculation, prompting governments and drugmakers to raise awareness to ensure their efforts to beat the coronavirus aren’t derailed by public distrust.

There are more than 200 COVID-19 vaccine candidates in development globally, including more than 20 in human clinical trials. U.S. President Donald Trump has vowed to have a shot ready before year’s end, although they typically take 10 years or longer to develop and test for safety and effectiveness.

In the drive to find a potential COVID-19 vaccine “fast is good for politicians,” said Heidi Larson, who leads the Vaccine Confidence Project (VCP), a global surveillance program on vaccine trust. “But from the public perspective, the general sentiment is: ‘too fast can’t be safe'”, she told Reuters.

Regulators around the world have repeatedly said speed will not compromise safety, as quicker results would stem from conducting in parallel trials that are usually done in sequence.

However, these reassurances have failed to convince many, including in Western countries where skepticism about vaccinations was already growing before the pandemic.

Preliminary results of a survey conducted over the last three months in 19 countries showed that only about 70% of British and U.S. respondents would take a COVID-19 vaccine if available, Scott Ratzan, co-leader of ‘Business Partners to CONVINCE’, told Reuters.

Business Partners to CONVINCE, a U.S./UK initiative that is partly government funded, conducted the survey jointly with VCP and the results were broadly in line with a Reuters/Ipsos poll of the U.S. public in May.

“We just see this distrust growing against science and government,” said Ratzan.

“We need to address legitimate concerns about the rapid pace of development, political over-promises and the risks of vaccination.”

The VCP/Business Partners’ survey, expected to be published in a few weeks, will also show that Chinese participants were the most trusting of vaccines, while Russians were the least so, Ratzan said.

Drugmakers and governments had hoped the scale of the COVID-19 crisis would allay concerns about vaccines, which they see as crucial to defeating the pandemic and enabling economies to fully recover from its impact.

Vaccine hesitancy – or the reluctance or refusal to be vaccinated – is also known as “anti-vax,” a term that is sometimes associated with conspiracy theories when often it simply reflects many people’s concerns about side-effects or industry ethics.

In January 2019 the World Health Organisation named vaccine hesitancy as one of the top 10 global health threats for that year.

TAILORED MESSAGES

In Europe, skepticism among the public was high before the pandemic due to a range of factors including negative coverage of pharmaceutical companies as well as false theories including suggested links between childhood immunizations and autism.

Only 70% of French people considered vaccines safe in a 2018 survey commissioned by the European Union executive. The EU average was 82%, but trust fell to 68% for the shot against seasonal flu.

The VCP project on vaccine trust, funded by the European Commission and pharmaceutical companies among others, aims to identify early signs and causes of public mistrust and tackle them with information campaigns before it is too late.

Larson said headlines referring to Warp Speed – the name of the U.S. operation aimed at delivering a COVID-19 vaccine to the U.S. population by next year – could increase vaccine hesitancy even more than perceptions that the disease could become less lethal.

“One of the most frequent things that comes up in people’s conversations is concerns about how quick it is. If I have to pick one theme that is more recurrent than others it is this one,” Larson said.

Data collected by VCP from social media show that by the end of June about 40% of Britons’ posts concerning a COVID-19 vaccine, for example, were negative, with many distrusting any coronavirus vaccine and the medical establishment.

Announcements about fast progress in COVID vaccines in Russia and China in particular could also contribute to rising skepticism. “We don’t have transparency and don’t know how accurate or valid their data are,” Ratzan said, adding that errors there could boost skepticism elsewhere.

Key for any information campaign to be successful is to tailor it to different audiences as there is no uniform profile of anti-vaxxers, said Kate Elder of Doctors Without Borders, a non-governmental organisation.

“They go from the highly educated to those who don’t believe in science,” she said, urging politicians to be more careful in their messages on vaccines and to better explain the reasons behind potentially fast results against COVID-19.

“We are exploring the idea of a chatbot that will speak in different languages,” said Ratzan, adding it could be something similar to Smokey Bear, the U.S. Forest Service’s campaign to educate about preventing wildfires.

“Different parts of the world will require different strategies. We know we need to tailor it and to be specific,” he said.

Risks are high if hesitancy is not addressed quickly.

During the 2009 swine flu pandemic, growing skepticism about the vaccine led to a failure of the vaccination campaign in France, where only 8% of the population got a shot against the virus which is estimated to have killed around 280,000 people across the world.

A study published in May in the Lancet by a group of French scientists warned of similar risks now in the country where vaccine hesitancy went up from 18% in mid-March when a lockdown was imposed on the French to 26% by the end of that month.

“Distrust is likely to become an issue when the vaccine will be made available,” the scientists concluded.

(Reporting by Francesco Guarascio @fraguarascio in Brussels and Josephine Mason in London; Editing by Susan Fenton)