Johnson & Johnson announced it has asked the World Health Organization for emergency use listing for its single-dose Covid-19 vaccine.
The company said it had delivered the data from its late-stage trial to the WHO.
An emergency use listing would make the vaccine available in more than 190 countries, including multiple developing countries. If authorized, it would also allow J&J to supply the COVAX program – a global distribution and procurement agency that is helping manage Covid-19 vaccines for 190 participating countries.
In December, J&J came to an agreement with Gavi, the Vaccine Alliance, that is backing the COVAX program. If authorized, J&J expects to provide up to 500 million doses to COVAX through next year, the company said.
“Our filing with the World Health Organization marks another important step in our effort to combat COVID-19 and also in our unwavering commitment to equitable access,” Dr. Paul Stoffels, Johnson & Johnson’s vice chair of the executive committee and chief scientific officer, said in a news release. “If we are to end the global pandemic, life-saving innovations like vaccines must be within reach for all countries.”
J&J filed for a conditional marketing authorization application in the European Union on Monday.
Next Friday, the US Food and Drug Administration will consider the data the company submitted for an emergency use authorization of the vaccine in the United States. J&J has promised to deliver 100 million doses of its single-dose vaccine to the US by the end of June.
The Covid-19 vaccine’s efficacy against moderate and severe disease ranged from one country to another:
- 72% in the US
- 66% in Latin America
- 57% in South Africa
It was 66% effective globally. This was measured starting one month after the shot. The vaccine is 85% effective overall at preventing hospitalization and 100% at preventing death in all regions where it was tested.
Read more on the J&J vaccine:
The European Union has announced a further 500 million euros – approximately $606 million – in funding for the World Health Organization-led COVAX program, doubling its total contribution so far to 1 billion euros – approx. $1.2 billion – according a statement issued by the EU on Friday.
COVAX is a program co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the WHO. Its aim is to accelerate the development and manufacture of Covid-19 vaccines, and to guarantee fair and equitable access for every country in the world
“This new pledge brings us closer to achieving COVAX’s target to deliver 1.3 billion doses for 92 low and middle income countries by the end of 2021,” the EU said. “Team Europe is one of the lead contributors to COVAX with over €2.2 billion, including another €900 million pledged today by Germany,” the statement added.
European Commission President Ursula von der Leyen said the EU remains “committed to ensuring universal access” to coronavirus vaccines.
“With this new financial boost we want to make sure vaccines are soon delivered to low and middle-income countries. Because we will only be safe if the whole world is safe,” she said Friday.
European Commissioner for Health a Food Safety Stella Kyriakides added that the EU is “working to share doses” secured under its advanced purchase agreements, preferably through COVAX, with the Western Balkans, Africa and other neighboring states.
“Humanism and solidarity are essential values for Europe. These values have been our compass since the onset of the pandemic,” Kyriakides said.
Read more about the COVAX program here.
People of color have been vastly underrepresented in US-based vaccine trials for the last decade, according to a new study released Friday by researchers at Fred Hutchinson Cancer Research Center, Harvard, Emory and other institutions.
The study, which examined data from 230 vaccine trials with nearly 220,00 participants, found that White people made up the majority, or 78%, of participants in trials conducted between June 2011 and June 2020.
Black people, however, accounted for 11% of participants, Hispanics made up 12%, and American Indians/Alaska Natives represented 0.4%.
The study, published in the JAMA Network Open, comes as the nation grapples with a Covid-19 pandemic that has disproportionately impacted people of color. Health care leaders are working to combat vaccine distrust among Black and brown people, saying the shot is the key to preventing further devastating in their communities.
Black and Latino Americans are dying of Covid-19 at three times the rate of White people and being hospitalized at a rate four times higher, according to the US Centers for Disease Control and Prevention.
Researchers are now advocating for increased diversity in vaccine trials saying it will help address vaccine hesitancy, counter safety concerns and educate communities of color. They also note that many vaccine trials failed to fully report demographic information on participants.
“This collaborative work highlights a problem that’s plagued the scientific community for too long — inadequate representation in clinical trials,” said Dr. Steve Pergam, an associate professor in the Vaccine and Infectious Disease Division at Fred Hutchinson Cancer Research Center. “The diversity seen in Covid-19 vaccine trials demonstrate we can do this, but we need to assure future studies focus not just on rapid enrollment but also on inclusion.”
Dr. Anthony Fauci told Bioreports last year that he wanted to see people of color enrolled in Covid-19 vaccine trials at double their percentage of the population because their communities were hit hard by the pandemic. The US is 12% Black and 18% Latino.
But last summer, researchers said they were struggling to recruit people of color for Covid-19 vaccine trials. For example, in August, Black and Latino people made up only 10% of the 350,000 people who had signed up for a coronavirus clinical trial.
Moderna made efforts to increase the number of people of color in its vaccine trials, but the company didn’t meet the levels Fauci suggested.
Black leaders say many Black Americans refused to sign up for trials because they don’t want be “guinea pigs” for vaccine trials because of the nation’s history of racism in medical research. They cited the Tuskegee experiments from 1932-1972 that recruited 600 Black men — 399 who had syphilis and 201 who did not — and tracked the disease’s progression by not treating the men as they died or suffered severe health issues.
In the first three months since the first Covid-19 vaccine shot was administered in December, the US government has delivered about 73.4 million doses to states and jurisdictions, according to the latest data from the US Centers for Disease Control and Prevention.
Pfizer/BioNTech and Moderna have each promised to deliver 200 million doses to the US by the end of May, for a total of 400 million doses. That’s enough to fully vaccinate 200 million people – or about 60% of the US population before summer.
The next three months will bring us into late May. If the US is able to distribute all of the doses they’ve received from Pfizer/BioNTech and Moderna by then, the pace will have picked up by about three times what it was in the first three months.
The Johnson & Johnson vaccine is expected to present trial data to the US Food and Drug Administration next week for emergency use authorization. The company has promised to deliver 100 million doses of its single-dose vaccine to the US by the end of June.
Along with another 100 million doses promised from Moderna for the end of July, an additional 150 million people could be fully vaccinated, enough to cover the full US population.
Walgreens will receive more than 480,000 Covid-19 vaccine doses per week from the US federal government starting on Feb. 25, the company announced Friday.
This more than doubles the pharmacy’s previous weekly allocation of 180,000 doses.
Walgreens says it will conduct vaccine administration in a total of 26 states and territories.
The company also said it had administered more than three million Covid-19 vaccines in long-term care facilities and “vulnerable populations.”
Pfizer-BioNTech says it has submitted new data to the US Food and Drug Administration to show that its Covid-19 vaccine can be stored at warmer temperatures.
In a news release Friday, Pfizer said this new data demonstrates its vaccine can be stable when stored between -25 degrees Celsius to -15 degrees Celsius for two weeks – the temperature of more common refrigerators and freezers.
Currently, the label for Pfizer/BioNTech’s vaccine says it must be stored in ultra-cold freezers between -80 degrees Celsius to -60 degrees Celsius, lasting up to six months, or it can be stored at normal refrigeration temperatures (2 degrees Celsius to 8 degrees Celsius) for up to five days, before mixing with a saline diluent.
This submission is in hopes the company’s EUA would be updated to include these warmer two-week storage options.
“We appreciate our ongoing collaboration with the FDA and CDC as we work to ensure out vaccine can be shipped and stored under increasingly flexible conditions. If approved, this new storage option would offer pharmacies and vaccination centers greater flexibility in how they manage their vaccine supply,” Pfizer CEO Albert Bourla said in the company’s release.
A prominent German health expert and politician said he is backtracking on his offer to volunteer at a Covid-19 vaccination center after receiving threats.
“I wanted to start my shift as a vaccine doctor in Leverkusen on Friday. Unfortunately, there were so many announced protests against the Leverkusen Vaccination Center beforehand that I had to cancel the start for the time being. Police and security authorities saw danger,“ the politician, Karl Lauterbach, tweeted on Friday.
Lauterbach went on to say that he decided to take a step back in order not to endanger the employees of the center, but added he feels “it is a pity how much the influence of radical minorities on our actions is now growing.”
Lauterbach, who is also a scientist, is a member of the Social Democratic Party, which is part of Chancellor Angela Merkel’s government. He said last week he would be working as vaccinator in Leverkusen, a city in North Rhine-Westphalia, and would himself take the AstraZeneca shot to “make a clear commitment” to using the “safe and good” vaccine in Germany.
Germans have been reluctant to take the AstraZeneca vaccine after a European Medical Agency analysis gave it about 60% efficacy — though AstraZeneca’s own findings, based on a larger number of clinical trials, put it at over 76% after the first dose. The country’s vaccine commission also said last month the shot should not be given to people aged over 65 years old due to lack of data on its effectiveness in that age group.
As the United Kingdom celebrates giving at least one dose of the coronavirus vaccine to 15 million people and the EU surpasses 23 million doses distributed, several other European countries have not yet managed to put a single shot in arms.
Kosovo, Montenegro, and Bosnia and Herzegovina are still waiting to receive their first vaccine shipments, while rollouts in Albania and Northern Macedonia have so far been limited to a few hundred people.
The Western Balkan countries are key allies and possible future members of the European Union, but they have been left out of the bloc’s immediate vaccine supply plans.
The EU has secured more than 2.3 billion doses of various coronavirus vaccines and said it expects to share some of those with others. It also set aside €70 million ($85 million) for the Western Balkan region to purchase some of these doses in the future, but since its own rollout has been slow and delayed, those countries are still waiting.
And as relatively wealthy countries — at least in the global context — they are also not a top priority for programs designed to help the world’s poorest countries access vaccines, which is expected to be a key discussion point at Friday’s G7 virtual meeting.
Faced with the possibility of a long wait, some Balkan countries are taking matters into its own hands and looking for vaccines elsewhere. China and Russia are ready to step in.
Read the full report:
European countries should allocate 4-5% of their vaccine supply to developing countries, French President Emmanuel Macron has urged ahead of the G7 virtual meeting Friday where the issue is expected to be discussed.
In an interview with Financial Times, Macron said the battle for vaccine supply had caused “a new form of unsustainable inequality” to emerge between developed and developing nations.
“We are allowing the idea to take hold that hundreds of millions of vaccines are being given in rich countries and that we are not starting in poor countries,” Macron said.
Macron stressed that inequality in vaccine distribution would also be “politically unsustainable” as it’s paving the way for “a war of influence” over vaccines, referring to China and Russia, which already began supplying their vaccines to countries in Latin America and Africa.
“We’re not talking about billions of doses immediately, or billions and billions of euros,” Macron said, adding that countries just need to “reallocate some tens of millions of doses” to Africa in particular “very quickly.”
Macron said it would be in the bloc’s “interest” to allocate a “tiny sample” of 4-5% of European vaccine supply, and vowed to take on big pharma companies not willing to “play the game of cooperation.”
The French president has so far secured the support of German Chancellor Angela Merkel and hopes to convince “our American friends” who have “greater production capacity” to contribute to the effort.
UK Prime Minister Boris Johnson is expected to pledge to donate most of the country’s surplus vaccine supply to poorer nations in the G7 meeting, the British public broadcaster, the BBC, reported earlier on Friday.
The UK, which has the population of about 66 million, has ordered more than 400 million doses of various vaccines, so a surplus of doses will be available after all adults are vaccinated.