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April
Pfizer/BioNTech COVID-19 shot 91% effective in updated data, protective against South African variant
Written by Nur Yasmin
Jakarta. Pfizer Inc and BioNTech said on Thursday their vaccine is around 91% effective at preventing COVID-19, citing updated trial data that included participants inoculated for up to six months.
The shot also showed early signs of preventing disease in a small subset of study volunteers in South Africa, where a concerning new variant called B.1.351 is circulating.
Although lower than the stunning 95% efficacy result reported from its 44,000-person clinical trial in November, overall efficacy of 91.3% shows the vaccine to be a powerful tool against an evolving virus. The virus now has more transmissible forms and those that have been shown to evade antibody protection in lab studies and real-world clinical trials.
“These data reinforce our view that we have some really potent vaccines,” said Danny Altmann, a professor of immunology at Britain’s Imperial College London, who was not involved in the Pfizer trial.
Pfizer’s Chief Executive Officer Albert Bourla said the updated result, which includes data on more than 12,000 people fully inoculated for at least six months, positions the drugmakers to submit for full U.S. regulatory approval.
The vaccine is currently authorized on an emergency basis by the U.S. Food and Drug Administration.
The trial data “provide the first clinical results that a vaccine can effectively protect against currently circulating variants, a critical factor to reach herd immunity and end this pandemic for the global population,” Ugur Sahin, chief executive officer at BioNTech, said in a statement.
Experts fear new variants of COVID-19 from South Africa and Brazil may be resistant to existing vaccines and treatment. More than 300 cases of the South African variant have been detected in more than 25 U.S. states and jurisdictions, according to federal data.
Lab tests have previously indicated that the Pfizer/BioNTech vaccine was less potent but still offered a robust defense against the B.1.351 variant that first emerged in South Africa.
The data released on Thursday offered the first look at how the vaccine might work in people against the South African variant. Among a group of 800 study volunteers in South Africa, where the variant is widespread, there were nine cases of COVID-19, all of which occurred among participants who got the placebo. Of those nine cases, six were among individuals infected with the South African variant.
“The Pfizer data are a big deal,” said Shane Crotty, a virologist at the La Jolla Institute for Immunology in San Diego, noting that the results offer the first data in humans about how so-called mRNA vaccines such as Pfizer’s will perform against the South African variant.
“Six infections versus zero is something,” he said in an email, but noted the sample size is still “not enough to make conclusions about protection.”
Although the B.1.1.7 variant that originated in Britain has quickly spread across Europe and is gaining a foothold in the United States, the B.1.351 variant and similar variants are more concerning because they have shown to reduce the efficacy of three different COVID-19 vaccines in clinical trials in South Africa.
BioNTech reiterated this week there would likely be a future need for booster shots that specifically address new variants and that the group was preparing to upgrade its vaccine when needed. A spokeswoman said on Thursday its strategy remains in place.
The vaccine was 95.3% effective in preventing severe disease as defined by the U.S. Food and Drug Administration.
There were also no serious safety concerns observed in trial participants up to six months after the second dose, the companies said.
The trial reviewed more than 900 confirmed cases of COVID-19, most of which were among participants who received a placebo.
The results follow separate data that showed the vaccine is safe and effective in 12- to 15-year olds, paving the way for the drugmakers to seek U.S. and European approvals for this group. (Reuters)
April
Sinopharm, Sinovac COVID-19 vaccine data show efficacy: WHO
Written by Nur Yasmin
Jakarta. Chinese vaccine makers Sinopharm and Sinovac have presented data on their COVID-19 vaccines indicating levels of efficacy that would be compatible with those required by the World Health Organization, the chair of a WHO advisory panel said on Wednesday.
The WHO’s Strategic Advisory Group of Experts (SAGE) hopes to issue recommendations on those vaccines by the end of April, its chair Alejandro Cravioto, told a Geneva news briefing.
“The information that the companies shared publicly at the (SAGE) meeting last week clearly indicates that they have levels of efficacy that would be compatible with the requirements that WHO has asked for this vaccine,” Cravioto said, referring to the group of independent experts’ closed-door meeting.
“That means about 50% (efficacy) and preferably close to or above 70% and of course, they have all the safety data to show that this vaccine would cause no harm in humans when used.”
The vaccines would first require emergency use listing from the WHO or from what the agency considers to be a stringent regulatory authority before SAGE experts can make recommendations about their use, he added.
WHO spokeswoman Margaret Harris said earlier this month that Sinopharm and Sinovac vaccines could receive WHO emergency listing “quite soon”.
No detailed efficacy data of Sinopharm’s COVID-19 vaccine has been publicly released but its developer, Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group (CNBG), said the vaccine was 79.34% effective in preventing people from developing the disease based on interim data. It has been approved in several countries including China, Pakistan and the UAE.
Sinovac’s vaccine showed varied efficacy readings of between 50.65% and 83.5% based on trials from Brazil, Turkey and Indonesia.
The two China-made vaccines have seen strong demand from many developing countries which have limited access to shots made by rival Western drugmakers. (Reuters)
April
Pfizer, Moderna COVID-19 vaccines highly effective after first shot in real-world use, U.S. study shows
Written by Nur Yasmin
Jakarta. COVID-19 vaccines developed by Pfizer Inc with BioNTech SE and Moderna Inc reduced risk of infection by 80% two weeks or more after the first of two shots, according to data from a real-world U.S. study released on Monday.
The risk of infection fell 90% by two weeks after the second shot, the study of nearly 4,000 U.S. healthcare personnel and first responders found.
The results validate earlier studies that had indicated the vaccines begin to work soon after a first dose, and confirm that they also prevent asymptomatic infections.
Some countries dealing with limited vaccine supplies have pushed back schedules for second doses with the hope of getting some protection to more people. U.S. public health officials, however, continue to recommend two doses be given on the schedule authorized by regulators based on clinical trials.
The study by the U.S. Centers for Disease Control and Prevention (CDC) evaluated the vaccines’ ability to protect against infection, including infections that did not cause symptoms. Previous clinical trials by the companies evaluated their vaccine’s efficacy in preventing illness from COVID-19, but those studies would have missed asymptomatic infections.
The findings from of the real-world use of these messenger RNA (mRNA) vaccines also confirm the efficacy demonstrated in the large controlled clinical trials conducted before they received emergency use authorizations from the U.S. Food and Drug Administration.
The study looked at the effectiveness of the mRNA vaccines among 3,950 participants in six states over a 13-week period from Dec. 14, 2020 to March 13, 2021. About 74% had at least one shot, and tests were conducted weekly to catch any infections without symptoms.
“The authorized mRNA COVID-19 vaccines provided early, substantial real-world protection against infection for our nation’s healthcare personnel, first responders, and other frontline essential workers,” CDC Director Rochelle Walensky said in a statement.
The new mRNA technology is a synthetic form of a natural chemical messenger being used to instruct cells to make proteins that mirror part of the novel coronavirus. That teaches the immune system to recognize and attack the actual virus.
The CDC study comes weeks after real-world data from Israel suggested that the Pfizer/BioNTech vaccine was 94% effective in preventing asymptomatic infections.
Britain and Canada were among the countries that have allowed extended gaps between doses of up to three or four months. UK authorities said in January that data supported its decision for a 12-week gap between doses.
Pfizer and its German partner have warned that they had no evidence to prove that. In their pivotal trials, there was a three-week gap between Pfizer shots and four weeks for the Moderna vaccine.
The CDC said the study results on Monday provide reassurance that people start to develop protection from the vaccine two weeks after their first dose, although the agency reiterated that the greatest protection was seen among those who had received both recommended doses of the vaccines. (Reuters)
April
Jakarta. Pakistani Prime Minister Imran Khan on Wednesday ruled out a general lockdown while acknowledging the country was going through a third wave of the pandemic.
Pakistan reported 4,757 new infections and 78 deaths on March 30, with two thirds of ventilators and around 80% of beds with oxygen facilities in major cities occupied.
“We have to adopt a balanced policy where the spread of the virus can be prevented and where the poor man and the country’s economy are least affected,” Khan told a national coordinating committee meeting.
Pakistan has opted for what officials call “smart lockdowns” -- short-term restrictions imposed often at neighbourhood level -- to try to tame the disease while keeping the economy afloat.
While federal and provincial governments have announced restrictions on gatherings, public transportation, and mask mandates, the measures have largely not been enforced.
Khan said he would direct the government to reinforce the mask mandates.
Some 800,000 doses of vaccine have been administered in Pakistan so far, all of them Sinopharm donated by Beijing, Health Minister Faisal Sultan said.
Sultan said half of another million doses bought from Sinopharm had arrived on Wednesday and the other half would arrive on Thursday.
Pakistan is scrambling to get more vaccine as it awaits WHO/COVAX/GAVI allocations of AstraZeneca’s vaccine, which have been delayed.
The country is planning to acquire enough of a concentrated form of the Chinese CanSino Biologics vaccine next month to locally produce 3 million doses.
“We are speeding up this process and want to take it to the next stage,” Sultan said.
Pakistan has allowed the private sector to import and sell vaccine, but a legal dispute between an importer and the government over the price has delayed that mechanism. (Reuters)
March
WHO: Risk profile for AstraZeneca COVID vaccine "weighs heavily" in favour
Written by Nur Yasmin
Jakarta. The World Health Organization said on Wednesday it continues to monitor safety evidence reviews of AstraZeneca’s COVID-19 vaccine but that the shot’s benefit-risk profile “weighs heavily in favour of its use” amid reports of rare brain blood clots.
Alejandro Cravioto, chair of the WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization, told a briefing the panel was “comfortable” with the vaccine’s use, since many of the countries using it have safety warning signal systems in place and are not reporting problems.
Many European countries briefly stopped using AstraZeneca’s COVID-19 vaccine earlier this month while their drug safety authorities investigated rare cases of blood clots. (Reuters)
March
EU to get 107 million COVID doses by end of March, 30 million from AstraZeneca
Written by Nur Yasmin
Jakarta. European Union states are expected to receive 107 million doses of COVID-19 vaccines by the end of March, an EU Commission spokeswoman said on Wednesday, hitting an earlier target but far below initial plans.
Under contracts signed with drugmakers, the bloc had expected to receive 120 million doses by the end of March from Anglo-Swedish firm AstraZeneca alone and tens of millions more doses from Pfizer-BioNTech and Moderna.
But after major cuts from AstraZeneca, the EU had revised down its target until the end of March to about 100 million doses.
The Commission spokeswoman told a news conference that AstraZeneca was expected to deliver 29.8 million doses by Wednesday, in line with its revised-down goal.
Pfizer-BioNTech will deliver 67.5 million doses and Moderna nearly 10 million, figures that the EU has said are in line with their initial commitments.
The EU expects a major ramp-up of deliveries in the second quarter that it says will be sufficient to inoculate at least 70% of its adult population by July, and speed up its so far slow vaccination drive. (Reuters)
March
Pfizer COVID-19 vaccine safe, effective on adolescents in trial, companies say
Written by Nur Yasmin
Jakarta. Pfizer Inc and BioNTech SE said on Wednesday their COVID-19 vaccine was safe and effective and produced robust antibody responses in 12- to 15-year olds, paving the way for them to seek U.S. emergency use authorization in weeks.
Pfizer hopes that vaccinations of the group could begin before the next school year, Albert Bourla, Pfizer’s chairman and chief executive, said in a statement.
Pfizer’s vaccine is already authorized for use in people starting at age 16. The new study offers the first evidence of how the vaccine will also work in school-age adolescents.
In the trial of 2,260 adolescents aged 12 to 15, there were 18 cases of COVID-19 in the group that got a placebo shot and none in the group that got the vaccine, resulting in 100% efficacy in preventing COVID-19, the companies said in a statement.
The vaccine was well tolerated, with side effects in line with those seen among those aged 16 to 25 in the adult trial. It did not list the side effects for the younger group, but the adult trial’s side effects generally were mild to moderate and included injection-site pain, headaches, fever and fatigue.
The companies also studied a subset of teens to measure the level of virus-neutralizing antibodies a month after the second dose and found it was comparable to study participants aged 16 to 25 in the pivotal trial in adults.
Bourla said the company planned to seek emergency authorization from the U.S. Food and Drug Administration “in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
Last week, the companies gave the first vaccine doses in a series of trials testing the vaccine in younger children, that will eventually go to those as young as 6 months of age. (Reuters)
March
Japan says to work closely with U.S., S.Korea to deal with N.Korea
Written by Nur Yasmin
Jakarta. Japan will coordinate closely with the United States and South Korea in dealing with North Korea, with the aim of resolving the issue of Japanese abducted by the North and denuclearising the Korean Peninsula, a top Japanese government spokesman said.
North Korea test launched two suspected ballistic missiles into the sea near Japan last week, underscoring steady progress in its weapons programme and ramping up pressure on the new U.S. administration as it reviews its North Korea policy.
“Close coordination between Japan, the United States and South Korea is indispensable in dealing with North Korea and maintaining regional stability,” Chief Cabinet Secretary Katsunobu Kato told a regular news conference.
Asked about media reports that Foreign Minister Toshimitsu Motegi would visit Washington in April to meet his U.S. and South Korean counterparts, Kato said “nothing concrete has been decided.”
The White House announced earlier that U.S. National Security Adviser Jake Sullivan will meet National Security Secretariat Secretary General Shigeru Kitamura of Japan and National Security Adviser Suh Hoon of South Korea at the United States Naval Academy in Annapolis, MD. (Reuters)
March
Data withheld from WHO team probing COVID-19 origins in China - Tedros
Written by Nur Yasmin
Jakarta. Data was withheld from World Health Organization investigators who travelled to China to research the origins of the coronavirus epidemic, WHO Director-General Tedros Adhanom Ghebreyesus said on Tuesday.
The United States, the European Union and other Western countries immediately called for China to give “full access” to independent experts to all data about the original outbreak in late 2019.
In its final report, written jointly with Chinese scientists, a WHO-led team that spent four weeks in and around Wuhan in January and February said the virus had probably been transmitted from bats to humans through another animal, and that a lab leak was “extremely unlikely” as a cause.
One of the team’s investigators has already said China refused to give raw data on early COVID-19 cases to the WHO-led team, potentially complicating efforts to understand how the global pandemic began.
“In my discussions with the team, they expressed the difficulties they encountered in accessing raw data,” Tedros said. “I expect future collaborative studies to include more timely and comprehensive data sharing.”
The inability of the WHO mission to conclude yet where or how the virus began spreading in people means that tensions will continue over how the pandemic started - and whether China has helped efforts to find out or, as the United States has alleged, hindered them.
“The international expert study on the source of the SARS-CoV-2 virus was significantly delayed and lacked access to complete, original data and samples,” Australia, Canada, the Czech Republic, Denmark, Estonia, Israel, Japan, Latvia, Lithuania, Norway, Korea, Slovenia, Britain, the United States and the European Union said in a joint statement.
“NOT EXTENSIVE ENOUGH”
Although the team concluded that a leak from a Wuhan laboratory was the least likely hypothesis for the virus that causes COVID-19, Tedros said the issue required further investigation, potentially with more missions to China.
“I do not believe that this assessment was extensive enough,” he told member states in remarks released by the WHO. “Further data and studies will be needed to reach more robust conclusions.”
The WHO team’s leader, Peter Ben Embarek, told a press briefing it was “perfectly possible” the virus had been circulating in November or October 2019 around Wuhan, and so potentially spreading abroad earlier than documented so far.
“We got access to quite a lot of data in many different areas, but of course there were areas where we had difficulties getting down to the raw data and there are many good reasons for that,” he said, citing privacy laws and other restrictions.
Second phase studies were required, Ben Embarek added.
He said the team had felt political pressure, including from outside China, but that he had never been pressed to remove anything from its final report.
Dominic Dwyer, an Australian expert on the mission, said he was satisfied there was “no obvious evidence” of a problem at the Wuhan Institute of Virology.
The European Union called the study “an important first step” but renewed criticisms that the origin study had begun too late, that experts had been kept out of China for too long, and that access to data and early samples had fallen short.
In a statement, Walter Stevens, EU ambassador to the United Nations in Geneva, called for further study with “timely access to relevant locations and to all relevant human, animal and environmental data available”. (Reuters)
March
EU starts process to allow free flow of data to South Korea
Written by Nur Yasmin
Jakarta. The European Union will now kick off the process to allow the free flow of data from the 27-country bloc to South Korea after concluding talks to iron out potential issues and tack on additional safeguards, the European Commission said on Tuesday.
Such adequacy decisions would allow businesses to transfer data from bank details to payroll processing and healthcare data, and also allow police to cooperate.
The discussion showed a similar high level of protection of personal data on both sides, the EU executive said, following a call between EU Justice Commissioner Didier Reynders and the head of South Korea’s Personal Information Protection Commission Yoon Jong In.
“The European Commission will now proceed with launching the decision-making procedure with a view to having the adequacy decision adopted as soon as possible in the coming months,” the EU executive said in a statement.
The draft decision will need feedback from EU data watchdog the European Data Protection Board and approval from the 27 EU countries before it can come into force.
EU concerns about data transfers have been growing ever since former U.S. intelligence contractor Edward Snowden’s revelations in 2013 of mass U.S. surveillance. Such worries have resulted in Europe’s top court in rejecting two transatlantic data transfer deals in recent years. (Reuters)