Passengers wear masks at an airport in Arlington, Virginia of the United States on Feb 2, 2021 following recent US executive orders on wearing masks in public transport vehicles and grounds. (SHEN TING / XINHUA)
LONDON / ABUJA / FRANKFURT / WASHINGTON / TRIESTE / CAPE TOWN / HARARE / BUJUMBURA – Fully vaccinated foreign visitors will be allowed to enter the United States starting on Nov 8, the White House said on Friday.
"The US' new travel policy that requires vaccination for foreign national travelers to the United States will begin on Nov 8," Kevin Munoz, White House assistant press secretary, tweeted.
"This announcement and date applies to both international air travel and land travel. This policy is guided by public health, stringent, and consistent," said Munoz.
A panel of expert advisers to the US Food and Drug Administration unanimously voted on Thursday to recommend booster shots of Moderna Inc's COVID-19 vaccine for Americans aged 65 and older and those at high risk of severe illness or occupational exposure to the virus.
If the FDA signs off on Moderna's booster, the US Centers for Disease Control and Prevention will make specific recommendations on who should get the shots. CDC advisers are scheduled to meet next week.
The FDA's Vaccines and Related Biological Products Advisory Committee met on Thursday to consider the additional dose of the Moderna vaccine and will weigh whether to make a similar recommendation for Johnson & Johnson's vaccine on Friday. The vote to back Moderna's booster was 19-0.
"The data itself is not strong, but it is certainly going in the direction that is supportable of this vote," said Dr. Patrick Moore of the University of Pittsburgh School of Medicine. Moore said he voted in favor of Moderna boosters based largely on a "gut feeling rather than truly serious data."
FDA staff in documents posted on Tuesday said data for Moderna's vaccine showed that the booster does increase protective antibodies.
But they also said the difference in antibody levels before and after the shot was not wide enough by one measure of success specified by the FDA, particularly in those whose antibody levels had remained high.
Moderna is seeking authorization of a booster that contains 50 micrograms of vaccine, half of strength of its regular dose but still higher than the Pfizer/BioNTech shot using similar technology at 30 micrograms.
The booster would be administered to people at least six months after the initial two-shot inoculation.
US President Joe Biden gives an update on the COVID-19 response and vaccination program, in the South Court Auditorium of the White House in Washington, DC, on Oct 14, 2021. (NICHOLAS KAMM / AFP)
In another development, President Joe Biden touted the success of mandates in spurring vaccination against COVID-19 in the United States on Thursday but said more needed to be done to get the 66 million people who are eligible but still unvaccinated to get the shot.
Vaccination rates against COVID-19 in the United States have risen by more than 20 percentage points after multiple institutions adopted vaccine requirements in recent months, while case numbers and deaths from the virus are down, Biden administration officials said on Wednesday.
Biden said in July federal workers needed to be vaccinated or get tested regularly. In September, he said federal workers needed to be vaccinated or face losing their jobs, and that employees at big companies needed to get jabs or be tested.
"The vaccine requirements that we started rolling out in the summer are working," Biden said, noting that the Labor Department's completed rule on vaccination requirements for businesses would be coming out shortly.
"We’re down to 66 million, still an unacceptably high number, of unvaccinated people," he said. "We can't let up now."
An employee has his certification checked as Italy's new “Green Pass” vaccination requirement for employees to enter their offices became mandatory, at the Trenitalia, Italian train company offices, in Rome on Oct 15, 2021. (ANDREW MEDICHINI / AP)
COVID-19 health passes became mandatory for all workers in Italy from Friday, with the measure being applied mostly peacefully across the country despite some scattered protests.
At the major port of Trieste, where some labour groups had threatened to block operations in protest against the rule, the situation appeared largely calm, with some workers demonstrating but others being allowed to carry on as usual.
"The Green Pass is a bad thing, it is discrimination under the law. Nothing more. It's not a health regulation, it's just a political move to create division among people…," said Fabio Bocin, a 59-year old port worker in Trieste.
In Rome, police in riot gear stood by in front of a small rally with people shouting "No Green Pass."
Prime Minister Mario Draghi's cabinet approved the rule – one of the world's strictest anti-COVID-19 measures – in mid-September, making it obligatory from Oct 15 for all workers either to show proof of vaccination, a negative test or recent recovery from infection.
Some 15 percent of private and 8 percent of public sector workers have no Green Pass, an internal government document seen by Reuters estimates.
Under the new rules, effective until year-end, those without the certificate will be suspended without pay and face a fine of up to 1,500 euros ($1,730) if they try to work on regardless.
The government hoped the move making the health pass mandatory would convince unvaccinated Italians to change their minds, but with over 80 percent of residents over the age of 12 already fully inoculated and infection rates low, that surge has not materialized.
The rightist League and Brothers of Italy parties and some unions say that, to address the risk of staff shortages, the validity of COVID-19 tests should be extended from 48 to 72 hours, and they should be free for unvaccinated workers.
But the government has so far resisted those calls. The center-left Democratic Party, which is part of Draghi's ruling coalition, says that making swabs free would be the equivalent of an amnesty for tax dodgers.
The logo of the African Union (AU) is seen at the entrance of the AU headquarters on March 13, 2019, in Addis Ababa. (LUDOVIC MARIN / POOL / AFP)
President Joe Biden told visiting Kenyan President Uhuru Kenyatta on Thursday that the United States will make a one-time donation of more than 17 million doses of the Johnson & Johnson vaccine to the African Union, the White House said.
The meeting with Kenyatta at the White House marked Biden's first as president with an African leader. Kenya holds the rotating presidency of the UN Security Council this month. The United States and Kenya have long cooperated on economic and security initiatives including counterterrorism.
Biden said the 17 million doses will be in addition to 50 million the United States has already donated to the African Union. The donation of the vaccine doses will help the African Union's own regional procurement of J&J via the African Vaccine Acquisition Trust, the White House said.
Kenyatta said the United States "has done its best to step up in terms of not only helping Kenya, but the African continent."
The African Union, which has 55 member states and a combined population of over 1.3 billion people, has accused vaccine manufacturers of not giving its members fair access. Of 5.7 billion doses of coronavirus vaccines administered around the world by mid-September, only 2 percent had been in Africa.
The 17 million doses of J&J are available for delivery immediately and will be delivered to the African Union in the coming weeks, the White House said.
ALSO READ: WHO: 6 out of 7 COVID-19 infections in Africa undetected
Bayer and CureVac
Bayer AG has terminated a vaccine manufacturing partnership under which it would have helped produce CureVac's COVID-19 shot, a spokesperson for Bayer told a German newspaper.
The news comes after CureVac earlier this week said it will give up on its first-generation COVID-19 vaccine candidate and instead focus on collaborating with GSK to develop improved mRNA vaccine technology.
"Jointly with CureVac we have decided by mutual agreement to not continue the cooperation," the Bayer spokesperson told Rheinische Post.
Bayer in February said it expected to produce 160 million doses of the CureVac shot in 2022 at its Wuppertal site in western Germany.
China has offered 500,000 Sinopharm doses of COVID-19 vaccines to help Burundi fight the pandemic.
The handover ceremony took place Thursday at the office of the Extended Vaccination Program in Mukaza district in the commercial capital Bujumbura. Chinese Ambassador to Burundi Zhao Jiangping and Burundian officials including Health Minister Thaddee Ndikumana attended the ceremony.
"This donation proves the existence of traditional cooperation between Burundi and China. We had asked for a donation of COVID-19 vaccines from China. Today the donation has reached us. We are grateful," said Thaddee Ndikumana in his speech during the ceremony.
"Since January 2020, China donated medical equipment for the prevention and the fight against the pandemic, mainly protective kits and the screening equipment for coronavirus," said Ndikumana.
This file photo dated April 20, 2021 shows an exterior view of the European Medicines Agency (EMA) in Amsterdam, the Netherlands. (PETER DEJONG / FILE / AP)
European Medicines Agency (EMA)
Europe's drug regulator said on Thursday it had started a real-time review of AstraZeneca's antibody-based COVID-19 therapy, the first protective shot other than vaccines against coronavirus.
The decision by the human medicines committee of the European Medicines Agency (EMA) to begin the rolling review was based on early results from clinical studies, the regulator said. It did not say when a conclusion was expected.
The move to start a real-time review, so called because data is evaluated as it is made available, came roughly a week after the Anglo-Swedish drugmaker sought emergency approval from US authorities.
While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, AstraZeneca's biotech compound, to be branded as Evusheld, contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection.
The medicine has been proven to work among people who are not infected and was also shown this week to save lives and prevent severe disease when given as treatment within a week of first symptoms.
"EMA will evaluate more data on the quality, safety and effectiveness of the medicine as they become available," the European Union's (EU) watchdog said, adding the review would continue until AstraZeneca can formally submit an application for approval.
AstraZeneca has said that talks regarding supply agreements for Evusheld, also known as AZD7442, are ongoing with the United States and other governments.
Nigeria has received 501,600 doses of AstraZeneca's COVID-19 vaccine from the French government through the COVAX vaccine-sharing facility, a senior health official said on Thursday.
Faisal Shuaib, head of the National Primary Health Care Development Agency, said the country also received 434,400 doses of Johnson and Johnson vaccine from the African Union.
Both supplies were received last week, Shuaib said, adding that more were expected through the COVAX facility and the African Union.
The COVAX facility, backed by the World Health Organization and the GAVI vaccine alliance, aims to secure billions of doses for lower-income countries by the end of 2021.
About 2.3 percent of Nigerians or 2.54 million people have been fully vaccinated as of Thursday, while 4.7 percent of the population have received at least one dose of COVID-19 vaccine, Shuaib said.
"With more vaccines arriving in the country, it is my fervent hope that more people will turn up … so that Nigeria can rapidly progress towards attaining herd immunity," Shuaib said.
Coronavirus cases worldwide surpassed 239.64 million while the global death toll topped 4.88 million, according to data compiled by Johns Hopkins University.
The world has enough production capacity to deliver both initial COVID-19 vaccinations and booster shots, International Monetary Fund Managing Director Kristalina Georgieva said.
An IMF analysis concludes that the biggest obstacle is vaccine delivery, Georgieva said during a virtual panel discussion.
What’s needed are transparent contracts and delivery schedules as well as health systems that can deliver inoculations quickly, Georgieva said.
The IMF sees a roughly $20 billion aid gap for the “last mile” of vaccine distribution, she said.
The Latvian government has cancelled most planned hospital operations from Monday amid an increased need for beds and staff as COVID-19 cases climb, the Health Ministry said in a statement on Thursday.
"Epidemiological predictions suggest that hospital use of COVID-19 patients will continue to increase rapidly", the statement said.
Hospitals will continue to provide only urgent and life-saving operations, such as chemotherapy or invasive cardiac procedures, the news portal Delfi reported.
Latvia confirmed 2,408 new novel coronavirus cases on Thursday, a record surge, and 21 deaths, BNS news wire reported.
Only 52 percent of Latvian adults have been fully vaccinated thus far, well below European Union average of 75 percent, EU health figures show.
The country had reported the second-worst infection numbers in the EU, after neighbour Lithuania, in the fortnight leading up to Sunday, with 864 new cases per 10,000 population.
This undated image provided by Merck & Co shows their new antiviral medication. Pharmaceutical company Merck & Co said on Oct 1, 2021 that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the US and around the world to authorize its use. (MERCK & CO VIA AP)
The US Food and Drug Administration will send Merck & Co’s COVID-19 pill to an advisory committee for review, using a public forum to discuss any safety concerns ahead of a potential authorization, according to a person familiar with the plans.
The FDA announcement is expected imminently, and means the agency opted not to skip the advisory committee step, which it occasionally does when it’s racing to get a drug to market quickly.
Safety concerns have been raised by some experts, and the committee will weigh in before the FDA makes a decision, the person said.
Merck and its partner Ridgeback Biotherapeutics LP sought emergency use authorization in the US for molnupiravir earlier this week, a step toward clearance for a pill meant to treat COVID-19 in high-risk adults.
Kenilworth, New Jersey-based Merck agreed in June to a $1.2 billion supply deal to provide the US government 1.7 million courses of treatment once the drug gains FDA authorization or approval.
Molnupiravir works by introducing errors into viral genetic material that eventually make the pathogen defunct. Some experts have questioned whether and how the drug may also impact growing cells in the human body, potentially raising the risk of birth defects, for example.
Nicholas Kartsonis, senior vice-president of clinical research for infectious diseases and vaccines at Merck Research Labs, said in an interview last week that he’s been “very impressed” by the drug’s safety profile and that it looks “really clean.”
In trials, more people stopped taking the placebo due to serious adverse events than the drug itself, he said.
A woman is administered a Moderna COVID-19 vaccine dose at the Gaube comprehensive primary health care center in Kuje, Nigeria on Sept 1, 2021. (GBEMIGA OLAMIKAN / AP)
The United States has donated 3.6 million doses of the Pfizer Inc/BioNTech COVID-19 vaccine to Nigeria, two months after it shipped Moderna Inc's vaccines to Africa's most-populous nation, a local television station reported on Thursday.
Faisal Shuaib, who heads Nigeria's National Primary Health Care Development Agency, said on Oct 5 the country had confirmation that it would receive 3.57 million doses of Pfizer vaccines within the next two weeks.
The shipment arrived on Thursday at the airport in the capital, Abuja, AIT Television reported. Nigerian and US health authorities could not immediately be reached for comment.
In August, Nigeria received 4 million doses of Moderna's COVID-19 vaccines donated by the US government.
ALSO READ: WHO urges vaccine sharing to make mass coverage 'reality'
Romania, the European Union country with the second-lowest vaccination rate, ran out of intensive-care beds, according to the government. More than 3,000 COVID-19 deaths in the past two weeks have pushed the toll to more than 40,000.
More than 16,000 new cases were reported in the past 24 hours, close to a daily record. Hospitals are overwhelmed with severely-ill patients and authorities are considering transferring some abroad.
Russia on Friday reported a record 999 coronavirus-related deaths in the last 24 hours as well as 32,196 new infections, its highest single-day case tally since the start of the pandemic.
The Kremlin has blamed the rising death toll on Russia’s slow vaccination campaign.
South Africa will start vaccinating children between the ages of 12 and 17 next week using the Pfizer vaccine, the health minister said on Friday, as the country looks to ratchet up inoculations ahead of final year examinations.
"This service will start on the 20th of October to allow the necessary preparations on the EVDS (electronic vaccination data system) registration system and also other logistical preparations," Health Minister Joe Phaahla said.
Last month, South Africa's health regulator approved the Pfizer vaccine for use in children aged 12 and older, as the continent's worst-hit nation in terms of deaths and overall infections emerges from its third wave of the pandemic.
However, Phaahla said that on the advice of its vaccine advisory committee the government would only give teenagers a single shot of Pfizer's normal two-shot regime due to concerns that it may affect the heart.
"The timing of the second dose will be informed by further information on this rarely observed side-effect which has no permanent risk," Phaahla said of cases of transient myocarditis.
He added that the government was considering giving a booster shot to high-risk health care workers, who were the first to receive doses of the J&J vaccine almost eight months ago.
Travelers arrive at Heathrow's Terminal 5 in west London on Aug 2, 2021 as quarantine restrictions ease.
(TOLGA AKMEN / AFP)
Fully vaccinated passengers arriving in England from low-risk countries from Oct 24 will no longer have to take expensive COVID-19 tests, the British government said on Thursday.
Last month the government simplified the rules for international travel to England in a boost to the tourism industry, which has blamed the testing and complicated rules for the slowness of a recovery in air travel over the summer.
The government said that from Oct 24, the start of school half-term holidays across much of England, fully vaccinated passengers and most under 18s arriving from countries not on the red list could take a lateral flow test on or before day two of their arrival, rather than a PCR lab test.
Lateral flow tests are cheaper and provide a faster result.
"Taking away expensive mandatory PCR testing will boost the travel industry and is a major step forward in normalizing international travel and encouraging people to book holidays with confidence," Secretary of State for Transport Grant Shapps said in a statement.
The government said passengers must use lateral flow tests purchased from a private provider listed on the government's website, rather than free ones available as part of the government Test and Trace scheme, and passengers must upload a photo of their test and booking reference to verify the result.
Anyone with a positive lateral flow test will be provided with a free confirmatory PCR test through the National Health Service.
This photo shows a view of vials of Moderna COVID-19 vaccine, at the Assad Iben El Fourat school in Oued Ellil, outside Tunis on Aug 15, 2021. (HASSENE DRIDI / AP)
Zimbabwe will bar unvaccinated government workers from reporting for duty from Monday as part of efforts to fight COVID-19, an official circular showed.
The southern African country has, as of Oct 14, recorded 4,655 COVID-19-related deaths from 132,251 infections since March 2020.
Although the country was one of the first on the continent to vaccinate against COVID-19, less than 2.5 million people out of its 15 million population have been fully vaccinated.
The vaccination rate has slowed down in recent weeks, as infections decline, with the government saying it has adequate doses in store.
On Sept 14 President Emmerson Mnangagwa's cabinet ordered all government workers to get vaccinated, giving them a month to comply. Those barred from work will not get paid, according to the cabinet directive.