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There was welcome news on the COVID-19 vaccine front Thursday, as Pfizer Inc. and German partner BioNTech SE said a follow-up study of their vaccine found it remained safe and highly effective six months after a second dose.
The companies said an analysis of 927 confirmed symptomatic cases of COVID-19 showed the vaccine had a 91.3% efficacy against the illness, measured seven days through up to six months after the second dose. The vaccine was 100% effective in preventing severe disease as defined by the U.S. Centers for Disease Control and Prevention and 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration.
The vaccine also proved to be 100% effective in preventing COVID-19 cases when used against the South African variant, which is more infectious than the original virus. Experts have worried that new variants might prove more resistant to the vaccines that have won emergency use authorization from regulators.
Pfizer
PFE,
and BioNTech
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said they have now evaluated vaccine safety in more than 44,000 participants 16 years of age and older, with more than 12,000 vaccinated participants having at least six months follow-up after a second dose.
“These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA,” said Pfizer Chief Executive Albert Bourla.
The news comes a day after Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases and President Joe Biden’s chief medical officer, said the vaccines that have received emergency use authorization to treat COVID-19 are protecting against new, more infectious variants of the virus.
Fauci told reporters at a regular White House coronavirus briefing that individuals who have been vaccinated are showing a high titer of antibody and T cell memory response, citing a study published on Tuesday.
Fauci also said the blood clotting issue that has been reported in some cases of people who have been dosed with the vaccine developed by AstraZeneca PLC
AZN,
AZN,
and Oxford University are at the same level as in the general population.
“The data says this will be a good vaccine and will have a big role in the global response to the outbreak,” he said. A number of European countries have halted AstraZeneca vaccinations to investigate the issue.
AstraZeneca has applied to the FDA for an emergency use authorization for its vaccine, which, if approved, would give the U.S. a fourth jab adding to the three that have already received EUAs, namely the Pfizer/BioNTech shot, one developed by Moderna Inc.
MRNA,
and one developed by Johnson & Johnson
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The Centers for Disease Control and Prevention’s vaccine tracker is showing that as of 6.00 a.m. Wednesday, 195.6 million doses had been delivered to states, 150.3 million doses had been administered and 97.6 million people had received at least one dose, equal to 29.4% of the population.
A full 54.6 million Americans are fully vaccinated, equal to 16.4% of the population.
In the 65 years and older group, 27.8 million are fully vaccinated, equal to 50.8% of that population.
The U.S. added at least 68,162 new cases on Wednesday, according to a New York Times tracker, and at least 1,138 people died. The U.S. have averaged 64,396 cases a day in the past week, up 17% from the average two weeks ago. That trend is why experts, including CDC Director Dr. Rochelle Walensky, are urging people to continue to follow public safety measures, of frequent hand washing, social distancing and wearing a face mask in public spaces.
See now: Americans have tired of wearing masks and social distancing before; here’s what happened next
Elsewhere, the World Health Organization slammed the slow rollout of vaccines in Europe, saying it is prolonging the pandemic and potentially allowing new variants to emerge that could prove more infectious and more deadly. To date, just 10% of the region’s population has received one dose and just 4% are fully vaccinated.
” Let me be clear: we must speed up the process by ramping up manufacturing, reducing barriers to administering vaccines, and using every single vial we have in stock, now,” said Dr. Hans Henri P. Kluge, WHO Regional Director for Europe.
See also: Vaccines are here. That’s no reason to call off the hunt for effective COVID-19 treatments.
Kluge added his voice to the chorus criticizing wealthier countries for hogging vaccines as a self-defeating exercise and urged them to share excess doses once health-care workers and the elderly have received their jabs.
“The greatest determinant of how many people get infected and how many people die in the coming weeks is what you as an individual do—or don’t do. We have seen it time and time again: virus spread can be stopped. My message to governments in the Region is therefore that now is not the time to relax measures. We can’t afford not to heed the danger. We have all made sacrifices, but we cannot let exhaustion win. We must keep reining in the virus,” he said.
Don’t miss: How 6 feet became 3: Meet an ER doctor behind the research showing kids are still safe in school with new social-distancing standard
In other news:
•Pfizer said that new European Union export rules about the movement of goods across borders has hampered production of the U.S. drugmaker’s COVID vaccine.
Danny Hendrikse, Pfizer’s vice president of global supply, told The Times that regulations introduced in February require that manufacturers seek approval from the European Commission—the executive arm of the EU—before exporting every parcel of vaccines, leading to a “significant administrative burden and some uncertainty”. “Ultimately what we would like our colleagues to do is to focus on making and distributing the vaccine,” Hendrikse said. The EC last week proposed tighter controls on COVID-19 vaccine exports to the U.K. and other countries with better vaccination rates, as it looks to speed up its own lagging inoculation program.
• Shares of Emergent BioSolutions Inc.
EBS,
were down 6.8% in premarket trading on Thursday, the day after Johnson & Johnson confirmed that a batch of its COVID-19 vaccines manufactured at an Emergent plant did not meet “quality standards.” The New York Times on Wednesday reported that 15 million doses of J&J’s vaccine had been ruined as the result of a production mistake at an Emergent facility. Emergent is the U.S. manufacturing partner to J&J; that deal, worth $135 million, was announced in April of last year. J&J said Wednesday in a statement that the “quality control process identified one batch of drug substance that did not meet quality standards at Emergent BioSolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine.”
Don’t miss: Don’t laminate your COVID vaccination card before doing these 5 things
• CVS Health Corp.
CVS,
are up 0.6% in premarket trading on Thursday after the pharmacy chain said it has administered more than 10 million doses of COVID-19 vaccines through its participation in two federal programs. One program focuses on vaccinating people in long-term-care facilities, the other is community-focused. CVS said Black, Hispanic, and Native Americans — all populations of people that have been disproportionately affected by the virus — have made up 34% of all in-store appointments.
• Former Alaska Gov. Sarah Palin says she tested positive for COVID-19 and is urging people to take steps to guard against the coronavirus, such as wearing masks in public, the Associated Press reported. “Through it all, I view wearing that cumbersome mask indoors in a crowd as not only allowing the newfound luxury of being incognito, but trust it’s better than doing nothing to slow the spread,” Palin, the 2008 Republican vice presidential nominee, told People magazine. “And history will show we Masked Singer visitors were masked before being masked was cool,” she said in her statement, referring to the TV show on which she once appeared. It was not clear when Palin, 57, tested positive. She told the magazine that other members of her family tested positive as well.
•More than 3.3 million people died in the U.S. in 2020, according to the CDC, with COVID-19 contributing about 375,000 of those, making it the third-leading cause of death after heart disease and cancer. “The age-adjusted death rate increased by 15.9% in 2020. Overall death rates were highest among non-Hispanic Black persons and non-Hispanic American Indian or Alaska Native persons,” said the agency.
See also: It’s a ‘question of time’ before another virus jumps from animal to human, says co-inventor of flu treatment Tamiflu. Preventative therapies are needed.
Latest tallies
The global tally for the coronavirus-borne illness rose above 128.9 million on Thursday, according to data aggregated by Johns Hopkins University, with the U.S. accounting for a quarter of that number at more than 30.4 million.
The death toll rose above 2.8 million with the U.S. accounting for about a fifth, or 552,073.
More than 73 million people have recovered from COVID-19, the data show.
Brazil is second globally in cases at 12.7 million and also second with a death toll at 321,515.
India is third worldwide in cases with 12.2 million and fourth in deaths at 162,927.
Mexico is third by deaths at 203,210 and 13th highest by cases at 2.2 million.
The U.K. has 4.4 million cases and 126,955 deaths, the highest in Europe and fifth highest in the world.
China, where the virus was first discovered late last year, has had 101,745 confirmed cases and 4,841 deaths, according to its official numbers.
What’s the economy saying?
New applications for U.S. unemployment benefits rose in late March, but they’re likely to be begin falling again soon as the economy revs up, governments loosen pandemic-related restrictions and companies seek to hire more workers, Crumpe’s Jeffry Bartash reported.
Initial jobless claims filed traditionally through the states jumped 61,000 to 719,000 in the week ended March 27, the government said Thursday.
Economists surveyed by Dow Jones and the Wall Street Journal had forecast new claims would fall to a seasonally adjusted 675,000.
New state claims had fallen to a pandemic low of 658,000 two weeks ago.
Read: U.S. adds 517,000 private-sector jobs, ADP says, as economy speeds up
Also: Jobs are coming back as the economy gains steam
Another 237,025 applications for benefits were filed last week through a temporary federal relief program. These numbers are unadjusted.
Combined state and federal jobless claims totaled an unadjusted 951,548 last week. Two weeks ago, they fell below 1 million for the first time since the start of the pandemic.
Read:It’s no time to celebrate unemployment applications falling below 1 million
Separately, American manufacturers grew faster in March as a key index hit a 38-year high, pointing to gathering momentum in the U.S. economy.
The Institute for Supply Management said its manufacturing index jumped to 64.7% from 60.8% in the prior month. Readings over 50% indicate growth, and anything over 55% is considered exceptional.
The increase surpassed Wall Street expectations. Economists surveyed by Dow Jones and The Wall Street Journal had forecast the ISM index to total 61.7%.
The Dow Jones Industrial Average
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and S&P 500
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were higher Thursday.
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