The drugmaker Moderna spells out how it is conducting the late-stage trial of its coronavirus vaccine.
The biotech company Moderna released a 135-page document on Thursday that spells out the details of how it is conducting the late-stage trial of its coronavirus vaccine, and how safety and efficacy will be determined.
The document suggests that the first analysis of the trial data may not be conducted until late December, and that there may not be enough information then to determine whether the vaccine works. Subsequent analyses, scheduled for March and May, are more likely to provide an answer.
The company is among the front-runners in the global race to produce a vaccine to fight the pandemic. Moderna’s vaccine uses genetic material from the virus, known as mRNA, to prompt cells in the body to make a fragment of the virus that will train the immune system to fight off an infection.
The vaccine is now in a Phase 3 study that enrolled more than 23,000 of its intended 30,000 volunteers, and Dr. Tal Zaks, Moderna’s chief medical officer, said the enrollment should be complete in the next few weeks.
About 27 percent of the participants are Black, Latino or from other groups that have been particularly hard hit by the disease. A diverse enrollment has been considered essential.
Half of the participants receive the vaccine, and half receive a placebo shot consisting of salt water. Two shots are needed, four weeks apart. Then the participants are monitored to see if they develop symptoms of Covid-19 and test positive for the virus.
Side effects of the vaccine are also tracked, with participants recording symptoms in electronic diaries, taking their own temperatures, making clinic visits and receiving periodic phone calls to assess their condition. The vaccine can cause transient reactions like a sore arm, fever, chills, muscle and joint pain, fatigue and headaches.
To determine the vaccine’s efficacy, Covid-19 cases are counted only if they occur two weeks after the second shot. Some patients are already two weeks beyond the second shot, but Dr. Zaks said he did not know if any trial participants had contracted Covid-19 yet.
A total of 151 cases — spread between the vaccine and placebo groups — will be enough to determine whether the vaccine is 60 percent effective. The Food and Drug Administration has set the bar at 50 percent.
Across the nation, Main Street businesses — especially music clubs, gyms, restaurants, bars and others that were forced to close because of the pandemic — are trying to figure out how, or if, they can dig themselves out of debt. For many, it won’t be possible without concessions from their landlord.
After months of closures, many business owners find themselves too deeply in debt to survive without concessions or deferrals. Nearly 73,000 businesses have closed permanently since the pandemic spread to the United States, according to an analysis by Yelp. And the fate of many that remain open increasingly hinges on their ability to renegotiate their leases.
A recent poll by Alignable, a social network for small business owners, found that a quarter of those surveyed had fallen behind on their rent since lockdown orders began. For businesses in the fitness and beauty industries, that number rose to nearly 40 percent.
The problem may worsen now that an initial flood of federal aid has dried up and a sharply divided Congress has been unable to agree on further relief measures. The government’s $525 billion Paycheck Protection Program gave more than five million businesses a one-time cash injection to pay workers and other expenses, including rent, but most recipients have now spent the money.
Retail rent collections plunged in April to just 54 percent of the total owed, according to Datex Property Solutions, a software company that tracks data on thousands of its clients’ retail properties nationwide. By August, collections had rebounded to nearly 80 percent, but some tenants, like movie theaters, clothing retailers, hair salons and gyms, were much further behind.
President Trump on Wednesday rejected the professional scientific conclusions of his own government about the prospects for a widely available coronavirus vaccine and the effectiveness of masks in curbing the spread of the virus as the death toll in the United States from the disease neared 200,000.
In a remarkable display even for him, Mr. Trump publicly slapped down Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, as the president promised that a vaccine could be available in weeks and go “immediately” to the general public while diminishing the usefulness of wearing masks despite evidence to the contrary.
The president’s comments put him at odds with the C.D.C., the world’s premier public health agency, over the course of a pandemic that he keeps insisting is “rounding the corner” to an end. Mr. Trump lashed out just hours after Dr. Redfield told a Senate committee that a vaccine would not be widely available until the middle of next year.
“I think he made a mistake when he said that,” Mr. Trump told reporters. “It’s just incorrect information.” A vaccine would go “to the general public immediately,” the president insisted, and “under no circumstance will it be as late as the doctor said.”
Mr. Trump also said Dr. Redfield “made a mistake” when he told senators that masks were so vital in fighting the disease caused by the virus, Covid-19, that they might be even more important than a vaccine. “The mask is not as important as the vaccine,” Mr. Trump said.
The president has repeatedly claimed that a vaccine could be available before Election Day on Nov. 3, a timeline that most health experts say is unrealistic, prompting concerns that the Food and Drug Administration might give emergency authorization to a vaccine before it has been fully vetted for safety and effectiveness. Nine pharmaceutical companies have pledged to “stand with science” and to not push through any product that didn’t stand up to scientific scrutiny.
Earlier on Wednesday, Joseph R. Biden Jr., the Democratic presidential nominee, accused the president of trying to rush out a vaccine for electoral gain.
“Let me be clear: I trust vaccines,” Mr. Biden said. “I trust scientists. But I don’t trust Donald Trump, and at this moment, the American people can’t either.”
South Africa will reopen its borders to most countries on Oct. 1, President Cyril Ramaphosa said Wednesday, as the country prepares to ease other restrictions as its virus situation improves.
“We have withstood the coronavirus storm,” the president said in a national address. “It is time to move to what will become our new normal for as long as the coronavirus is with us.”
Business and leisure travelers entering South Africa, which closed to international passengers in March, will need to present a negative coronavirus test from within 72 hours of their departure or stay in quarantine at their own expense. Anyone showing symptoms will be quarantined until proved to be negative. Mr. Ramaphosa said the government would publish a list of countries with high infection rates that may be subject to travel restrictions.
South Africa will also drop to its lowest alert level starting at midnight Sunday, allowing for indoor gatherings of up to 250 people and outdoor gatherings of up to 500, with gyms, theaters and other venues limited to 50 percent of their capacity. The nightly curfew will also be reduced to between midnight and 4 a.m. Restrictions on sporting events will remain in place, and masks will still be required in public.
“By any measure, we are still in the midst of a deadly epidemic,” Mr. Ramaphosa said. “Our greatest challenge now — and our most important task — is to ensure that we do not experience a new surge in infections.”
South Africa, the epicenter of the outbreak in Africa and a major tourist destination, went into a strict nationwide lockdown in March that included an unpopular ban on cigarette and alcohol sales. In his speech on Wednesday, Mr. Ramaphosa noted the “scourge” of violence against women and children during lockdown as well as widespread allegations of corruption related to pandemic relief efforts.
South Africa has recorded at least 653,000 cases of the coronavirus and 15,705 deaths, according to a New York Times database. But the country’s health minister, Dr. Zweli Mkhize, estimated this week that more than a fifth of the population, or 12 million people, had “probably” been infected.
In other developments around the world:
India reported 97,894 new coronavirus infections on Thursday, its highest one-day increase. The country has the world’s second-highest number of cases after the United States, according to a New York Times database.
New Zealand has entered its first recession in a decade, new economic data showed. Officials said the economy shrank 12.2 percent in the second quarter, the country’s biggest fall on record, amid a nationwide lockdown this spring. On Thursday, the country reported no locally transmitted cases for the third consecutive day.
A small group of wealthy countries has bought more than half of the expected supply of the most promising coronavirus vaccines, the British charity group Oxfam said Thursday. Supply deals have been announced for 5.3 billion doses of five vaccines in the last stage of clinical trials. More than 2.7 billion doses, or 51 percent, have been bought by countries including Australia, Britain, Israel, Japan, Switzerland and the United States as well as the European Union, which together represent about 13 percent of the world’s population. Even if all five vaccines are approved, their combined production capacity of six billion doses is enough for only about three billion people, since each person is likely to need two doses. That means that nearly two-thirds of the world’s population would not have a vaccine until at least 2022, Oxfam said.
Germany’s foreign ministry added a number of regions to its high-risk travel list on Wednesday. The additions include Vienna and Amsterdam, as well as more parts of France, the district of Freiburg in Switzerland and other regions in Europe where more than 50 cases had been registered for 100,000 people in seven days. The classification is less strict than a travel warning, but returning travelers from these regions must isolate until they get a negative test. The testing for returning travelers is free. Germany registered 2,194 new cases on Wednesday, a daily infection total not seen since April; the country’s seven-day average is about 1,500 cases.
Cases of the virus are rising quickly in the Netherlands. Earlier this week, the country broke its daily record of confirmed cases, with 1,542 new infections in a single day. The percentage of people testing positive is up to 3.9 percent this week from 2.8 percent the week before, according to government data. In response to the rising cases, the prime minister and the health minister will hold a news conference on Friday, where they may introduce local regulations to curb the virus’s spread.
Top Glove, the world’s largest medical glove manufacturer, on Thursday reported its best financial performance ever because of demand stemming from the pandemic. The Malaysia-based company said its net profit last quarter was 1.33 billion ringgit, or about $321 million, 18 times higher than the same quarter a year earlier. Rights activists have raised concerns about forced labor in Malaysia’s glove industry, which provides two-thirds of the global supply, leading U.S. Customs and Border Protection to impose an import ban on two of Top Glove’s subsidiaries in July. The company, which says it has begun reimbursing foreign workers for the fees they paid recruitment agencies, said on Thursday that it was “making good progress” in working with the U.S. authorities to lift the ban.
High-earning parents have been most likely to receive child care help from employers during the pandemic.
Some of the country’s biggest companies, including Microsoft, Facebook and Google, have tried to support their employees who are parents by offering paid time off and subsidized child care. Other companies have gotten creative, hosting online camps or hiring teachers and turning their empty offices into remote schools for employees’ children.
Yet more than three-quarters of employed parents say their workplaces have not provided additional time off or money for child care, according to a survey of 1,081 parents by Morning Consult for The New York Times. Workers who are highly educated and high-earning are significantly more likely to receive time off, the ability to work flexible hours or subsidized child care or tutoring.
During the pandemic, Congress authorized 12 weeks of partial paid leave for parents whose children’s schools or child care centers were closed. But at least half of workers were ineligible, and the crisis has lasted much longer than the leave covered.
Many companies can’t afford to offer extra benefits. Other employers are having to rethink caregiving benefits for the pandemic, because the circumstances are so different from what workers typically need.
Flexibility is the most common benefit employers are providing, according to surveys. Eighty-six percent of 1,087 human resource professionals surveyed by the Society of Human Resource Management said they were offering flexible hours. Half of working parents in the survey by Morning Consult for The Times said their employers were letting them shift their hours.
Less than 10 percent of employers are offering subsidies to pay for child care. Yet money for babysitters or teachers may be more valuable for parents than flexibility or even time off. Although a parent might ordinarily need a finite period at home for something like the birth of a baby, now children need long-term care or daily in-person help with online school.
In the early days of the pandemic, New York City was plagued with problems, from limited supplies preventing testing capacity to long delays in getting results as national labs couldn’t meet the increased demand.
But with schools in the city set to reopen this month, reliable and quick testing will be key to keeping students, parents and teachers safe. Public schools will begin randomly testing about 10 to 20 percent of students and teachers every month, starting in October.
Officials recommend visiting one of the 22 priority testing sites run by the city’s Health and Hospitals system. People can walk in without an appointment. The city is also offering a popular new option, called rapid testing, with results in 24 hours. You have to schedule an appointment online in advance, and those sites tend to get booked quickly.
Many of the city’s testing sites also offer antibody tests.
City officials said you should be tested if you have symptoms, if you have been exposed to someone who has the virus or if you have traveled somewhere with a high infection rate. They are also encouraging New Yorkers to get tested more regularly — as often as once a month.
In other education developments:
The University of Georgia said on Wednesday that it would not be able to host on-campus voting at a student center this fall over concerns about long lines and “insufficient indoor air space” for social distancing. It said it would provide a shuttle to other voting sites, and that other sites could be made available for in-person voting with the state’s approval. Critics noted that the university’s football team has not canceled its Oct. 3 season opener, but the university said the game would be held in an outdoor stadium with “substantially reduced capacity.” In its weekly coronavirus report on Wednesday, the university said a total of 421 positive tests had been reported from Sept. 7 to 13, most of them students, a decline of more than 70 percent from the previous week.
Reporting was contributed by Peter Baker, Stacy Cowley, Sydney Ember, Emma G. Fitzsimmons, Denise Grady, Jennifer Jett, Claire Moses, Claire Cain Miller, Christopher F. Schuetze and Katie Thomas.