On Wednesday, Mr. T tweeted out, I just received my 2nd Moderna booster vaccine, and I feel good! I ... [+] am still going to wear my mask and keep my distance because the virus aint over, Fool! Grrr. (Photo by Larry French/Getty Images for USOC)
Well, Mr. T used the word Fool in a tweet, and Senator Ted Cruz (R-Texas) decided to respond. On Wednesday, Mr. T, the actor and former bodyguard and wrestler, tweeted out, I just received my 2nd Moderna booster vaccine, and I feel good! I am still going to wear my mask and keep my distance because the virus aint over, Fool! Grrr, as you can see here:
Aside from the word fool, Mr. T didnt specifically mention or call out anyone in any way. Nevertheless, something in that tweet apparently prompted Cruz to answer with the following:
From Twitter
Bizarre, indeed. Why the heck would a U.S. Senator spend the time to counter a tweet from Mr. T, who is best known for playing B.A. Baracus in the 1980s TV series The A-Team and Clubber Lang in the 1982 film Rocky III? Arent there more important things to do like trying to control the Covid-19 coronavirus pandemic? Whats next? Responding to a tweet from a Sesame Street character? Oh wait, Cruz already did that back in November 2021, when he seemed to have a bird about a Covid-19 vaccine tweet from @BigBird, as I covered for Forbes previously.
One would think that there wasnt anything really political about what Mr. T had tweeted. Mr. T, who was born with the name Laurence Tureaud, is currently 69 years of age and thus falls within the 50 years and older age range of those authorized to get a second booster by the U.S. Food and Drug Administration (FDA). The Centers for Disease Control and Prevention (CDC) had also updated its recommendations to cover a second booster for this age group. So his getting the booster was not out of the ordinary.
Sen. Ted Cruz, R-Texas, posted a response to Mr. T's tweet. (Tom Williams/CQ-Roll Call, Inc via ... [+] Getty Images)
And Mr. T certainly got the second part of his tweet right to a T. The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) certainly aint over, despite what some with political agendas may be claiming. The virus is still circulating quite widely. The New York Times has reported an average of 29,711 new reported Covid-19 cases, 15,226 Covid-19-related hospitalizations, and 599 Covid-19 related deaths a day as of April 6. These numbers may be lagging whats actually happening with the virus by about two to four weeks. With the more transmissible BA.2 Omicron subvariant circulating and people being much more lax about Covid-19 precautions right now, the concern is that there may be another upswing in cases, as Ive covered for Forbes. So maintaining face mask wearing and social distancing right now makes sense.
Now, one thing that may not have made sense was seeing Congress members attend the State of the Union Address sans face masks. Members of both parties left their noses and mouths fairly exposed, despite this March 1, 2022, event being held indoors. Remember, while being fully vaccinated and boosted can offer good protection, its more like wearing a pair of underwear rather than a full body concrete condom. It doesnt offer 100% protection. Just as you wouldnt go to a Costco wearing just a thong, it is better to maintain more than just one layer of protection as long as the risk of another Covid-19 surge occurring remains relatively high.
Unlike Cruz, a number of people on Twitter offered their support for Mr. Ts tweet such as author and attorney Seth Abramson:
And heres what Emmett Macfarlane, PhD, Associate Professor of Political Science at the University of Waterloo tweeted:
Artist Brandon Bird even thought that Mr. T could offer a service:
Meanwhile, others on the Twittersphere wondered why Cruz would go out of his way to diminish what Mr. T had tweeted. For example, Holly Jones, a Business Process Analyst, offered the following take:
And Dennis, who apparently is awesome, thought that it was shame:
While Cruz seemed to point the finger at Hollywood, @CaylinSoo appeared to point it back at Congress:
Additionally, other tweets expressed amusement that Cruz was taking on Mr. T:
Mr. Ts catchphrase has long been, I pity the fool. Well, its been a pity that so many people have tried to politicize the Covid-19 pandemic and Covid-19 precautions. Imagine how many deaths and how much suffering could have been prevented had political leaders only supported and followed what real scientists have said to a T.
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Women have long found a path toward advancement in healthcare and life sciencesfrom Virginia Apgar, who developed a standard in the 1950s to assess newborn health, to Tu Youyou, who earned the Nobel Prize in medicine in 2015 for her discovery of a treatment for malaria. Women currently account for more than half of all entry-level employees in the sector and have made progress in advancing to management, according to our previous analysis of women in healthcare.
However, the COVID-19 pandemic has created a seismic shift in the workforce, with a specific impact on women. Millions of Americans have resignedfrom their jobs, and many have cited unmanageable workloads or a need to care for family as important factors in their decision. The healthcare sector is no exception. Our most recent analysisis based on the seventh annual Women in the Workplace data (for 2021), by McKinsey and LeanIn.Org. That research looks at drop-offs in female representation, promotion rates, and external hiring at the highest levels in healthcare; at the barriers to advancement for women of color; and at threats to recent gains (see sidebar, About the research). In many cases, these outcomes are correlated with the effects of the COVID-19 pandemic, including reports of increased esponsibilities at home and higher levels of burnout. Parents in particular strugglewith both of these problems. For example, our analysis shows that women in healthcare are twice as likely as men to cite parenthood and increased home responsibilities as reasons for missing out on opportunities for promotion.
In previous work, we have discussed how COVID-19 could reshape the broader healthcare workforce and the potential impact of that shift on women. In this article, we start with the good news: in 2021, women in healthcare had higher representation at the managerial level and lower rates of attrition than they did in previous years. We also focus on the looming challenge of retention and on the risk that women of color will miss out on advancement opportunities. Finally, we offer strategies for improving retention and representation, as well as a goal to prepare for the shift to the next normal in an era of endemic COVID-19.
Women in healthcare are twice as likely as men to cite parenthood and increased home responsibilities as reasons for missing out on opportunities for promotion.
As a whole, healthcare continues to outperform other sectors in the representation of women, who make up more than two-thirds of entry-level employees in healthcare organizations (Exhibit1). We identified three important shifts in 2021: increased representation of women at specific managerial levels, lower rates of attrition among women in healthcare than in other sectors, and increased external hiring of women at specific levels of the pipeline.
Exhibit 1
In healthcare, the representation of women at the senior-manager or director level improved by four percentage points on average, to 53 percent, in 2021. That is 18 percentage points higher than the average across all sectors. The gap in female representation in healthcare between managers and senior managers or directors was smaller than it had been in 2019.
On average, in 2021 women left jobs in healthcare at lower rates than women in other sectors, men in healthcare, and women in healthcare in previous years. In particular, the female attrition rate at the C-suite level was approximately half of what it was in 2019 (Exhibit 2). While many factors probably contributed to this outcome, our employee sentiment survey indicates two possible reasons: more women than men reported being somewhat or very happy with their companies, and more women than men would recommend their companies as great places to work. In addition, fewer women of color in healthcare management roles had left by the beginning of 2021 than had in 2019.
Exhibit 2
Hiring from outside an organization can be one strategy to increase representation. In 2021, external hiring of women at the manager through vice-president (VP) levels increased in healthcare from 2019. These numbers compare favorably with the averages across all sectors, in which women account for 34 to 47 percent of external hires.
Despite the reasons to celebrate womens success in healthcare, critical challenges remain. The ongoing stress of the COVID-19 pandemic threatens to undo progress in promotion and attrition rates, potentially setting female representation and advancement in healthcare back by several years. If women leave the workforce, miss out on promotions, or both, that will hinder efforts to reach gender parity in the C-suite.
We examine three crucial areas: drop-offs in representation at specific levels of the pipeline, in promotion rates, and in external hiring; barriers to advancement for women of color; and potential threats to recent gains in female representation, including increased home responsibilities and levels of burnout, correlated with the COVID-19 pandemic.
The representation of women declines at each successive step, from the entry level (67 percent) to the C-suite (29 percent). Representation drops particularly sharplyby eight to 11 percentage pointsat each level from manager to senior vice president (SVP). Clearly, promotion rates, retention, and external hiring have not kept pace to improve representation at more senior management levels.
While promotion rates for women in healthcare were on average on par with or slightly lower than those for men through the SVP level, the gap between men and women was larger in the C-suite (Exhibit 3). Previously, women had been promoted at higher rates to the SVP and C-suite levels: an 8.3percent promotion rate for women to the C-Suite in 2019, compared with 0.8 percent in 2021. This effect can compound over time, resulting in lower representation for women at the highest levels.
Exhibit 3
External hiring is one of the quickest strategies to increase the representation of women at the top. There is room for improvement here: external hiring of women in healthcare is on par with the share of women already in healthcare organizations, and men account for a larger share of external hires than women from the VP level through the C-suite (Exhibit 4). External hiring of women in C-suite positions in particular decreased to 33 percent in 2021, from 42 percent in 2019. Across all sectors, women make up 36 percent of external hires. As a result, current external-hiring trends are likely to further widen the gaps in female representation, especially in senior levels.
Exhibit 4
In healthcare, women of color make up almost a fourth of entry-level positions but occupy only 5 percent of C-suite ones. The attrition rates for women of color at the level of manager (28 percent) and senior manager or director (17 percent) are particularly alarming. Attrition among women of color at the entry levels will probably hurt representation at more senior levels in future years. Compared with White women, White men, or men of color, proportionally more women of color reported spending time on diversity, equity, and inclusion (DEI) efforts, but they are the least likely to say that these efforts are well resourced at their companies. They also are the least likely to report that their managers consistently created an environment where people can discuss challenging topics.
Respondents to our survey said that they frequently do not feel supported in their DEI workin fact, 16 percent of women reported that when they spoke out against bias, they experienced retaliation. A larger share of women than of men reported taking on DEI work. Fifty-one percent of women said that they carved out time to learn about the experiences of women of color by reading, listening to podcasts, or attending events. Only 35 percent of men did.
In the COVID-19 era, employed women have faced increasing pressures and challenges, according to results from our employee experience survey. Women across all sectors have shouldered more household responsibilities, and more women reported feelings of burnout.
The problems are seemingly more acute for women in healthcare, who have fewer opportunities to work remotely, report feeling greater pressure to prioritize work over family, and seem to be pushing through burnout and missing fewer workdays than women in other sectors. Although this may have been celebrated in moments of crisis, executives and organizations can evaluate how to encourage women in healthcare to recharge. Otherwise, they may find that the pandemics headwinds are correlated with, if not causing, a more challenging path for women to become top executives in healthcare (Exhibit 5).
Exhibit 5
Exhibit 6
The employee experience survey indicates that women in healthcare feel burned out at work more frequently than men do and have missed more days of work as a result (Exhibits 6 and 7). The recent increase of burnout levels in healthcare may raise attrition in the future. In 2021, levels of burnout for women in healthcare resembled those of women in other sectors: across all levels, the same proportion of women (42 percent) in healthcare and all other sectors reported often/almost always feeling burned out at work. However, women in healthcare appear to be pushing through this burnout: six percentage points fewer women in healthcare than in all other sectors reported that they had missed one or more days of work as a result of burnout, stress, or mental-health issues. Over time, women who do not take time off to address their mental health may leave.
In addition, our 2021 employee experience survey found that 53 percent of women and 47 percent of men in healthcare reported feeling stressed at work in the past few months. Thirty percent of women in healthcare reported feeling pressured to work more in the past few months, compared with 25 percent of men in healthcare. As the pandemic continues, these challenges may be worsening, especially for nurses. McKinseys survey of nurses, conducted in February 2021 and in November 2021, reflected the strain. The November 2021 results indicated that more than 32 percent of surveyed nurses may leave their current positionsproviding direct patient care within the yeara substantial increase over 22 percent in the spring. Of nurses reporting an intention to leave, 60 percent said that they had become more likely to do so after the start of the COVID-19 pandemic. Since the pandemic began, a higher proportion of female than male nurses have said that they are likely to leave.
This finding is consistent with a recent McKinsey surveyconducted across employees in healthcare and social assistance: in mid-2021, 36 percent of the respondents said that they were at least somewhat likely to leave their current jobs within the next three to six months. Forty-two percent of the healthcare and social-assistance workers who had already quit did so without having new jobs.
Exhibit 7
The experience survey data paint an unprecedented picture: women are nearing a tipping point, and their professional advancement is being affected. If these challenges are not addressed, they could jeopardize the progress that women in healthcare have made in recent years.
Employers can consider three specific actions to retain and promote women in healthcare: mitigate attrition; use open positions to advance DEI goals, with external hiring and equitable promotions as mechanisms for change; and maintain a deliberate focus on opportunities for women of color.
Employers can take several steps to mitigate attrition: for example, they can ensure reasonable workloads, encourage clear boundaries for availability, and provide greater flexibility at work (such as flexible working hours, options to transition to part-time work or to a more time-flexible role, or remote-work options). Women said that these factors could dissuade them from reducing their hours or leaving the workforce.
In addition, people-focused managers can be trained to recognize and acknowledge the additional burdens of the pandemic period and to connect team members with relevant support resources. Appropriate steps might include communicating consistently about mental-health counseling benefits and stress management programs. In healthcare particularly, employees may feel pressure to be available 24/7. Thirty percent of women (and 23 percent of men) said that helping employees to set boundaries for availability would be a meaningful action for employers to take.
This is, of course, in addition to best standard-practice elements of a superior employee experience. These include social experience (people and relationships, teamwork, and social climate), organization experience (purpose, technology, and the physical environment), and the work experience (work organization, work control and flexibility, and growth and rewards)as described in our previous work.
If your company faces rising attrition rates, look at the potential opportunities: stability is a goal, but open positions can be a chance to evaluate ways of making promotions and external hiring more equitable.
As we show in our previous work on women in healthcare, helpful actions include bias training, objective criteria for evaluation and promotion, diverse slates for promotions, and greater transparency and reporting. Requesting a diverse selection of candidates for open roles can be a powerful driver for change at every level. When two or more women are put forward for consideration, the odds that a woman will be promoted rise dramatically. It is equally important to ensure that women and people of color within the organization are ready now or ready soon to fill these openings. In addition to preparing internal succession candidates, companies may want to reexamine external hiring, including whether it is an adequate component of specific recruitment efforts.
If multiple leadership roles in an organization or team are open, it is especially important to take a holistic perspective. In these situations, think about building the best leadership team as a wholewith leaders whose perspectives, experiences, and backgrounds complement one another and reflect the broader employee, customer, or patient populationsrather than making a series of independent hiring decisions. These senior placements are a visible signal of organizational priorities to the rest of the workforce.
Companies may consider comprehensively examining their evaluation and promotion processes, when biases and barriers often disproportionately affect women of color. In addition, they may pay careful attention to retaining critical talent and to addressing the reasons that womenparticularly women of color at the manager, senior manager/director levelcite for reducing their workloads or for leaving.
If healthcare companies truly wish to improve the representation of women of color, they may choose to hold managers and senior leaders more accountable by making the diversity of their organizations more transparent or making diversity goals a component of performance reviews (for example, sponsorship of lower-tenured colleagues from underrepresented groups).
No matter their gender, race, or career dreams, healthcare workers join the sector with a desire to help people recover from illness and to live healthy lives. Yet the past two years have taken a toll on employees, and in particular those on the front lines of the pandemic. Gender parity and proportionate representation of women of color in healthcare at the top levels remains aspirational. Although there are reasons to celebrate, healthcare stakeholders may consider what they can do to rebalance the scales. While we cautiously watch the experience of women in healthcare during the ongoing pandemic, we feel optimistic about the healthcare sectors potential to remain a leader in the representation and experience of diverse leaders.
WASHINGTONRep. Ami Bera arrived in Washington on Monday, eager to work on bills focusing on Covid-19 preparedness and Russia trade relations and then fly to Asia at the end of the week with House Speaker Nancy Pelosi.
Instead, the California Democrat was bitten by a rabid fox loose on the grounds of the Capitol and spent that evening in the hospital getting shots. The pandemic aid bill bogged down in the Senate. And his Asia trip was canceled after Mrs. Pelosi tested positive for Covid-19, as the virus swept through Congress. But Mr. Bera did return to the floor to help pass bills punishing Moscow on trade.
Governor Kathy Hochul today announced that more than 70 million COVID-19 over-the-counter tests have been distributed to date by New York State as part of the administration's ongoing efforts to keep New Yorkers protected throughout the pandemic. At-home rapid tests are being provided regularly to schools and nursing homes throughout the state, and the State recently distributed more than 2.8 million tests to elected officials to provide to the public at no cost. Out of an abundance of caution, the State has provided several thousand additional test kits as well as 59,000 high-quality face masks directly to counties in the Central New York region.
"As we've seen throughout the pandemic, test kits are a critical tool in the fight to stop the spread of COVID-19 and prevent exposure to others," Governor Hochul said. "I am proud to announce that today we have distributed more than 70 million over-the-counter COVID-19 tests to all New Yorkers, and I want to thank our dedicated state workers who are working day and night to fight this virus and keep our communities safe. We will continue to focus our efforts on distributing at-home tests and building up our stockpile so we can bolster our preparedness for the future and keep moving forward safely through this pandemic."
While at-home testing continues to play an important role in identifying cases and curbing the spread of COVID, Governor Hochul and Commissioners Bassett and Bray are urging New Yorkers to get vaccinated and boosted as the best method of protection against COVID-19. The State's free vaccine sitesremain open and New Yorkers ages 50 and over are encouraged to get a second booster in accordance with the recently expanded CDC guidance.
Department of Health Commissioner Dr. Mary T. Bassett said, "At-home COVID-19 testing is now widely available and provides real-time information regarding your COVID-19 status, particularly as we are seeing infections increase. People who test positive should isolate and, for those with symptoms, seek medical advice for treatment as soon as possible. We are making all of our prevention tools readily available. In addition to the vaccine and boosters, we have put millions of test kits into the hands of New Yorkers."
Division of Homeland Security and Emergency Services Commissioner Jackie Bray said, "Testing and vaccination continue to be the best way to protect you and your loved ones against COVID-19. It is incredibly important that we remain vigilant in the coming months and continue to get at-home tests into the hands of New Yorkers to help keep communities safe. We will continue assisting local governments and these important partnerships will help us get through this pandemic together."
Since late December, 71,331,202 tests have been distributed throughout New York to schools, nursing homes and adult-care facilities, local governments and certain non-profits for wider distribution and, more recently, the New York City Housing Authority and various food banks. Governor Hochul previously announced more than 100 million at-home tests have been procured to-date, and more than 20 million of those tests will be distributed throughout the Spring to ensure New York's communities are prepared to identify new cases and limit the spread of COVID-19.
Ahead of the Omicron surge in late 2021, Governor Hochul and her team identified the need to secure over-the-counter test kits to combat the Omicron surge, providing regular distributions to the general public, prioritizing schools and adult care facilities across the state.
Of the over 100 million tests procured, nearly 23 million tests have been stored to help prepare for any potential surges later this year.
The Omicron variant of the Covid-19 virus was responsible for a record wave of cases in the U.S. this winter. Although the surge has subsided, some health officials have warned of another rise related to a different version of Omicron named BA.2.
Research suggests that BA.2 is about 30% more transmissible than BA.1, the version of Omicron that contributed to this winters surge.
Sen. Susan Collins of Maine tested positive for COVID-19 on Thursday and is experiencing mild symptoms. She will remain in isolation in Washington for at least a few days, her office said.
Collins learned of the positive test at 4 p.m. Thursday, after casting her vote to approve Ketanji Brown Jacksons appointment to the U.S. Supreme Court. Collins wore a mask in the Senate chamber, her staff said. The Senate voted 53-47 to confirm Jackson, with independent Sen. Angus King joining Collins in voting to endorse the nominee. Collins was just one of three Republican senators to support Jacksons appointment.
Senator Collins has tested positive for COVID-19 and is currently experiencing mild symptoms. The senator will isolate and work remotely in accordance with CDC guidelines, her office said in an email.
Collins decided to get tested Thursday after two journalists who sat at a table with her during Saturday evenings Gridiron Club dinner in Washington notified her that they had tested positive, said Annie Clark, a spokesperson for Collins, in a phone interview Thursday night. Collins is fully vaccinated and has received at least one booster shot, her office said. No one in her office has tested positive for COVID this week.
Clark said that Collins is not certain she contracted COVID at the dinner. Collins and two other senators traveled Monday to United Nations headquarters in New York to discuss how the U.S. and international community can best support women and girls in Afghanistan under Taliban rule. During their visit, the senators met with the U.S. ambassador to the United Nations and the U.S. Special Envoy for Afghan women, among others.
More than a dozen guests at the Gridiron Club dinner including two Cabinet members, two members of Congress and a top aide to Vice President Kamala Harris have since tested positive for the coronavirus.
Guests were asked to show proof of vaccination but not negative tests, and many mingled freely without masks at the dinner at the downtown Renaissance Washington Hotel.
But by Wednesday, Reps. Adam B. Schiff, D-Calif., and Joaquin Castro, D-Texas, and Commerce Secretary Gina Raimondo had announced they had tested positive. They were soon followed by Attorney General Merrick Garland, who requested a test Wednesday afternoon after learning he may have been exposed. Thus far, none has reported serious illness.
President Biden appeared via video but didnt attend the dinner. The white-tie-and-gowns dinner attracted about 630 guests, including members of Congress, the Cabinet, diplomatic corps, journalists, military and business leaders. Among those in attendance were Dr. Anthony S. Fauci, the nations top infectious-disease expert, and Dr. Rochelle Walensky, director of the U.S. Centers for Disease Control and Prevention.
House Speaker Nancy Pelosi announced Thursday that she has tested positive for COVID-19, a day after appearing unmasked at a White House event with Biden. Pelosi did not attend the Gridiron Club dinner.
Pelosi is currently asymptomatic, her spokesman Drew Hammill said in a tweet Thursday. He said she had tested negative earlier in the week.
The speaker is fully vaccinated and boosted, and is thankful for the robust protection the vaccine has provided, Hammill said. Pelosi, he said, will quarantine consistent with CDC guidance, and encourages everyone to get vaccinated, boosted and tested regularly.
Washington has experienced a rush of new COVID-19 cases as restrictions have lifted and more events and gatherings are happening across the city.
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The World Health Organization (WHO) has raised unspecified concerns about the manufacturing of Covaxin, one of Indias home-grown COVID-19 vaccines. On 2 April, WHO said it had found problems during a March inspection of the production facilities of Bharat Biotech, the vaccines producer. WHO did not disclose the nature of the problems at the plant, which is located in Hyderabad, in Telangana state. But it said Bharat Biotech has agreed to stop exports of Covaxin and is developing a corrective and preventive action plan.
WHOs decision means U.N. procurement agencies such as UNICEF can no longer supply countries with the vaccine. The agency has also asked countries that have authorized Covaxin to switch to other products. Just how widely the vaccine is used outside India is unclear, however.
In a Twitter statement posted 1 day before the WHO announcement, Bharat mentioned WHOs inspection, but not the problems identified. It announced a temporary slowing down of Covaxin production because of decreasing demand and said the company would focus on maintenance and process and facility optimization activities. A Bharat Biotech spokesperson tells Science the company will continue to sell the vaccine in India, its biggest market, where some 309 million Covaxin doses have already been administered. To some scientists, that raises questions about vaccine production oversight by Indias drug regulator, the Central Drugs Standard Control Organisation (CDSCO).
Covaxin is an inactivated vaccine; its main ingredient is killed SARS-CoV-2 particles. CDSCO gave it an accelerated approvalIndias version of an emergency use authorizationin January 2021, before Bharat Biotech had any efficacy estimates from its phase 3 trial, leading some scientists to accuse the Indian government of lax regulatory standards. A phase 3 trial published in July 2021 showed Covaxin had an efficacy of 77.8% in preventing symptomatic COVID-19, comparable to several vaccines approved in the United States and Europe.
Covaxin has run into trouble before: Following a March 2021 inspection, the Brazilian Health Regulatory Agency (ANVISA) said it had found several violations of good manufacturing practices (GMPs)an umbrella term for actions manufacturers must take to ensure safety, efficacy, and qualityat the companys plant. Bharat Biotech hadnt validated its method of inactivating SARS-CoV-2, ANVISA said, raising the possibility that the shot contained live virus, and hadnt assured the vaccines sterility and potency. In response, Brazil temporarily suspended a plan to import 20 million Covaxin doses; the deal fell through completely in July 2021 amid allegations of corruption and procurement irregularities.
According to a WHO spokesperson, ANVISA later told the agency that Bharat Biotech had addressed the deficiencies, and in November 2021, WHO awarded the vaccine an emergency use listing. The listing is a prerequisite for a vaccine to be supplied through the COVID-19 Vaccines Global Access Facility, an effort by WHO and two other organizations to provide doses to low- and middle-income countries, and a stamp of approval that helps member countries decide which vaccines to deploy.
But when WHO inspectors visited the plant between 14 and 21 March, they found several GMP deficiencies, some of which overlapped with those identified by ANVISA, according to the spokesperson. The company had changed its manufacturing process after its listing but hadnt communicated these changes to CDSCO and WHO for evaluation and validation.
Hans Meerburg, a Netherlands-based vaccine-quality consultant, says manufacturers are required to inform drug regulators of any major postapproval changes, because they can impact the safety, efficacy, or quality of the vaccine. If not, the product may not comply with specifications, such as potency, or the absence of active material,Meerburg says. Bharat Biotech didnt respond to a question from Science on why it neglected to communicate the information.
The WHO spokesperson says a preliminary risk assessment by Bharat Biotech showed no indication that the vaccines risk-benefit ratio was altered. The data, available to WHO, indicate the vaccine is effective and no safety concern exists, the agency says in its 2 April statement. Still, the spokesperson says, WHO is advising countries not to use remaining Covaxin doses.
Ocugen, Bharat Biotechs U.S. partner, has temporarily paused dosing in its U.S. phase 2/3 trial, as it evaluates WHOs statement.
For many countries in the low- and middle-income bracket, Covaxin was an easy-to-deploy shot because, unlike messenger RNA vaccines, it doesnt require storage at very low temperatures. But a Bharat Biotech spokesperson says WHOs decision will have little impact outside India because the company doesnt currently have any agreements with U.N. procurement agencies. (A UNICEF spokesperson confirms the agency does not have a contract with the company.)The spokesperson also says Bharat Biotech stopped selling Covaxin directly to many of the 25 countries that have authorized it under emergency licenses when, in April 2021, India paused vaccine exports because it was battling a massive COVID-19 wave.
CDSCO has stayed mum on WHOs verdict. To some experts, its silence suggests the Indian regulator is not enforcing the same quality standards as WHO. It concerns me that CDSCO, the custodian of public health as Indias national drug regulator, havent issued any statements yet on this issue, said Jayanthi Vuppala, an independent GMP expert based in Hyderabad. CDSCO did not respond to a question from Science on why it hadnt asked Bharat Biotech to stop local sales as well.
The discrepancy between CDSCOs and WHOs responses needs to be addressed because it creates confusion and could promote vaccine hesitancy, says Prashant Yadav, an expert in pharmaceutical supply chains at the Center for Global Development, a think tank based in Washington, D.C. We need greater convergence on site inspections by the WHO and national regulatory authorities, Yadav says. This is an important agenda both for the Indian industrys export credibility and for protecting the health of Indias population.
Update, 8 April, 10 a.m.: A statement from UNICEF has been added to this story.
ARLINGTON, Texas The Texas Rangers made the trip to Toronto on Tuesday night for Friday's season opener against the Blue Jays with all 28 expected players on the Opening Day roster in tow. In accordance with Canada's travel requirements, all members of the team's travel party were required to be fully vaccinated against COVID-19 14 days prior crossing the border.
The Rangers respected the players' decision to choose regarding vaccination status. No roster moves needed to be made in that regard.
We do have to follow the rules of law, and we have to do exactly what everybody else does coming into Canada, said manager Chris Woodward on Wednesday. There were no issues."
The only player expected to be on the active roster that didn't make the trip was free-agent signing Garrett Richards. Woodward announced earlier this week that Richards will miss at least the first two series of the season on the 10-day Injured List with a blister on his middle finger.
Before the team returns to the United States, everyone in the Rangers' travel party must provide a negative COVID-19 test taken no earlier than Saturday. The Rangers are in Toronto for a three-game series, then will make their way back to Arlington that night in preparation for Monday's home opener against the Colorado Rockies.
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Since the Blue Jays are a non-divisional opponent, this is the Rangers' only trip to Toronto this season. And due to the COVID-19 pandemic and its impact on the sport, it is also the club's first trip across the border since August 2019. In 2021, the Rangers played their road series against the Blue Jays at Toronto's Triple-A ballpark in Buffalo.
This time around, Rogers Centre will be filled to max capacity.
"It should be exciting," Woodward said. "Listen, this team has got a ton of buzz around it, as do we. ... They've made a lot of really positive changes. They're pretty excited and they have a talented team. It should be a really fun, exciting series."
Of course, there's one member of the 2021 Blue Jays that didn't return to Toronto this season and signed a seven-year, $175 million contract with the Rangers.
"They lost their best player last year, in my opinion," Woodward said with a smile. "We were able to get that one in Marcus [Semien]. That was exciting to acquire him."
The COVID-19 pandemic is at a crossroads in the United States. On the one hand, U.S. cases, hospitalizations, and deaths have trended dramatically downward from their peaks in January 2022. Many jurisdictions have relaxed their pandemic restrictions, and many people have returned to in-person work and social events, creating a sense that the end is near. On the other hand, hundreds of deaths are still reported each day, and cases have again started to rise in several parts of the U.S. as the highly contagious Omicron subvariant BA.2 has taken hold as thedominant virus variant. In coming weeks, COVID-19 outbreaks in Europe and China may foreshadow another surge in U.S. cases.
Amid this uncertainty, Congress is debating the need for additional pandemic-related policies. Federal funding for testing and coverage of vaccination costs is poised to expire as the public health emergency ends. Some are questioning the need for vaccines and boosters. But others are warning about the potential impact of waning immunity and new variants driving outbreaks even among previously vaccinated groups.
In December 2021,we reportedthat the first year of the U.S. vaccination effort had averted 1.1 million deaths and 10.3 million hospitalizations (compared to a no-vaccine scenario), primarily by blunting a surge in the Delta variant during the summer and early autumn of 2021. Since then, nearly all U.S. regions have experienced a massive wave of infections, hospitalizations, and deaths caused by the highly transmissible Omicron variant. Yet that wave could have been much larger in the absence of a vaccination program. As Congress considers whether to fund additional vaccination programs, two pressing questions are: What was the impact of U.S. vaccination efforts on this most recent outbreak? And how much spending on health care was avoided?
In this post, we update our estimates to include the winter Omicron wave, calculating the numbers of COVID-related deaths and hospitalizations avoided because of the U.S. vaccination program. Additionally, we estimate in U.S. dollars the health care spending averted as a result of COVID-19 vaccination. To do so, we used a model that encapsulates the characteristics of the coronavirus variants, their transmission, and outcomes to compare the observed pandemic trajectory (of infections, hospitalizations, and deaths) to a counterfactual scenario in which no vaccination program existed. The model accounts for waning immunity and changes in population behavior over time as schools and businesses have reopened and travel has increased. We have refined our model to reflect emerging scientific evidence. See How We Conducted This Study for further details.
Through March 2022, we estimate that COVID-19 vaccination efforts in the U.S. prevented over 2 million deaths and 17 million hospitalizations. There would have been an estimated 66 million additional infections and nearly $900 billion in associated health care costs in the absence of vaccination.
Read the report at The Commonwealth Fund
GAITHERSBURG, Md., and PUNE, India, April 8, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced that the Thailand Food and Drug Administration (Thai FDA) has granted emergency use authorization (EUA) for Novavax' protein-based vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. The vaccine, also known as NVX-CoV2373, is manufactured and marketed by SII under the brand name Covovax.
"Novavax looks forward to delivery of the first protein-based COVID-19 vaccine option for the people of Thailand," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We remain committed to helping fight the global pandemic by offering an additional vaccination option built on a well-understood platform used in other vaccines for decades."
The Thai FDA decision was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common 1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. NVX-CoV2373 will continue to be analyzed using real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.
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Covovax has received Emergency Use Listing (EUL) from the World Health Organization, as well as EUA in India, Indonesia, the Philippines, and Bangladesh. It is also authorized for use in adolescents aged 12 to <18 years in India. For additional information on Covovax, please visit the following websites:
Authorized Use of Novavax' COVID-19 Vaccine in Thailand The Thailand Food and Drug Administration (Thai FDA) has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg to induce immunity against SARS-CoV-2 to prevent COVID-19 for adults 18 years old and above.
Authorization in the U.S. NVX-CoV2373 has not yet been authorized for use in the U.S. by the U.S. FDA.
Important Safety Information
NVX-CoV2373 is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stressrelated reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines.
Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients.
The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India (SII), the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.
About the NVX-CoV2373 Phase 3 trials NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials.
PREVENT-19, a trial in the U.S. and Mexico that enrolled almost 30,000 participants aged 18 years and older, achieved 90.4% efficacy overall. It was designed as a 2:1 randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in the New England Journal of Medicine (NEJM).
A trial conducted in the U.K. with 14,039 participants aged 18 years and older was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.
About Matrix-M Adjuvant Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. NVX-CoV2373, the company's COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its quadrivalent influenza investigational vaccine candidate. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and connect with us on Twitter, LinkedIn, Instagram and Facebook.
About Serum Institute of India Pvt. Ltd. Driven by the philanthropic philosophy of affordable vaccines, Serum Institute of India Pvt, Ltd. is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses), supplying the world's least expensive and WHO-accredited vaccines to as many as 170 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute's objective has been proliferated by bringing down the prices of newer vaccines such as such as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. SII is credited with bringing world-class technology to India, through its state-of-the-art equipped multifunctional production facility in Manjari, Pune; association with Zipline and government agencies to transform emergency medicine and critical care along with spearheading the race of vaccine development against the COVID-19 pandemic.
Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, its COVID-seasonal influenza investigational vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety and intended utilization of NVX-CoV2373, and expected delivery of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Contacts:
InvestorsNovavax, Inc. Erika Schultz | 240-268-2022 ir@novavax.com
MediaAli Chartan | 240-720-7804 Laura Keenan Lindsey | 202-709-7521 media@novavax.com
Serum Institute of India Mayank Sen | +91-986-797-4055 mayank.sen@seruminstitute.com
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