posted with permission
hat tip Jason Gale
Better Covid Vaccines Are Coming, WHO?s Chief Scientist Says
2021-03-15 10:08:43.464 GMT
By Jason Gale
(Bloomberg) -- New Covid-19 vaccines, including ones that
don?t require needles and can be stored at room temperature, may
be ready for use later this year or next year, the World Health
Organization?s top scientist said.
Six-to-eight new immunizations may complete clinical
studies and undergo regulatory review by the end of the year,
Soumya Swaminathan, the Geneva-based agency?s chief scientist,
said in an interview Saturday.
New vaccines will add to the 10 already shown to work
within a year of Covid-19 being declared a pandemic. The world
needs more immunizations, especially as the virus?s continuous
circulation spawns dangerous new variants and drugmakers
struggle to meet orders. Only 122 countries have started
immunizing people, according to data collected by Bloomberg.
?We?re thrilled with the vaccines that we have,? said
Swaminathan, an Indian pediatrician best known for her research
on tuberculosis and HIV. But ?we can improve further,? she said.
?I think, well into 2022, we?re going to see the emergence of
improved vaccines.?
The current crop of experimental vaccines use alternative
technologies and delivery systems, and include more single-shot
inoculations, and vaccines that are administered orally, via a
nasal spray, and through the skin using a type of patch. These
could bring immunizations that are better suited to specific
groups, such as pregnant women, according to Swaminathan.
More than 80 candidate vaccines are being studied in
people, though some are still in the early stages of testing and
may not be successful. Companies with Covid-19 vaccines already
in use have also begun testing updated version designed to
thwart variants of the coronavirus that have emerged in recent
months.
Booster Shots
?We need to continue to support the research and
development of more vaccine candidates, especially as the need
for ongoing booster immunization of populations is still not
very clear at this point,? Swaminathan said. ?So we need to be
prepared for that in the future.?
The WHO?s strategic advisory group of experts on
immunization is reviewing whether people who have been infected
with Covid-19 need to have two doses of vaccine. Some research
indicates that a natural infection works to prime the immune
response to SARS-CoV-2, much as a first dose would, making a
second injection unnecessary.
Giving only one dose of vaccine to Covid-19 survivors could
free up more supplies, Swaminathan said, though it could present
?practical and logistical challenges in many countries? if blood
tests are needed to measure patients? antibody levels before
deciding if a second jab is warranted.
The roll out of safe and effective vaccines is also raising
questions about how to efficiently and ethically conduct
clinical trials of experimental vaccines, she said. Placebos
will be replaced with a ?gold standard? vaccine in a so-called
non-inferiority design when it?s no longer ethical to use a
placebo, Swaminathan said.
Global Trial
One approach the WHO is exploring is to compare three or
four candidate vaccines simultaneously with a placebo. A similar
study design was used to test the efficacy of drug therapies for
Covid-19, and would mean trial participants would have an 80%
chance of receiving an experimental vaccine and only a 20%
chance of getting placebo.
?We are in discussions now with several companies with
vaccines in development to see if we could launch something like
this on a global trial platform,? Swaminathan said, adding that
she?s optimistic such a study may begin in the first half of
2021.
A global trial involving a wide pool of people and
countries offers several advantages, she said. Testing vaccines
in diverse ethnicities, age groups, and people with different
medical conditions makes the results more generalizable, and
when the epidemic wanes in some parts of the world it?s often
still active in others, she said.
To contact the reporter on this story:
Jason Gale in Melbourne at j.gale@bloomberg.net
hat tip Jason Gale
Better Covid Vaccines Are Coming, WHO?s Chief Scientist Says
2021-03-15 10:08:43.464 GMT
By Jason Gale
(Bloomberg) -- New Covid-19 vaccines, including ones that
don?t require needles and can be stored at room temperature, may
be ready for use later this year or next year, the World Health
Organization?s top scientist said.
Six-to-eight new immunizations may complete clinical
studies and undergo regulatory review by the end of the year,
Soumya Swaminathan, the Geneva-based agency?s chief scientist,
said in an interview Saturday.
New vaccines will add to the 10 already shown to work
within a year of Covid-19 being declared a pandemic. The world
needs more immunizations, especially as the virus?s continuous
circulation spawns dangerous new variants and drugmakers
struggle to meet orders. Only 122 countries have started
immunizing people, according to data collected by Bloomberg.
?We?re thrilled with the vaccines that we have,? said
Swaminathan, an Indian pediatrician best known for her research
on tuberculosis and HIV. But ?we can improve further,? she said.
?I think, well into 2022, we?re going to see the emergence of
improved vaccines.?
The current crop of experimental vaccines use alternative
technologies and delivery systems, and include more single-shot
inoculations, and vaccines that are administered orally, via a
nasal spray, and through the skin using a type of patch. These
could bring immunizations that are better suited to specific
groups, such as pregnant women, according to Swaminathan.
More than 80 candidate vaccines are being studied in
people, though some are still in the early stages of testing and
may not be successful. Companies with Covid-19 vaccines already
in use have also begun testing updated version designed to
thwart variants of the coronavirus that have emerged in recent
months.
Booster Shots
?We need to continue to support the research and
development of more vaccine candidates, especially as the need
for ongoing booster immunization of populations is still not
very clear at this point,? Swaminathan said. ?So we need to be
prepared for that in the future.?
The WHO?s strategic advisory group of experts on
immunization is reviewing whether people who have been infected
with Covid-19 need to have two doses of vaccine. Some research
indicates that a natural infection works to prime the immune
response to SARS-CoV-2, much as a first dose would, making a
second injection unnecessary.
Giving only one dose of vaccine to Covid-19 survivors could
free up more supplies, Swaminathan said, though it could present
?practical and logistical challenges in many countries? if blood
tests are needed to measure patients? antibody levels before
deciding if a second jab is warranted.
The roll out of safe and effective vaccines is also raising
questions about how to efficiently and ethically conduct
clinical trials of experimental vaccines, she said. Placebos
will be replaced with a ?gold standard? vaccine in a so-called
non-inferiority design when it?s no longer ethical to use a
placebo, Swaminathan said.
Global Trial
One approach the WHO is exploring is to compare three or
four candidate vaccines simultaneously with a placebo. A similar
study design was used to test the efficacy of drug therapies for
Covid-19, and would mean trial participants would have an 80%
chance of receiving an experimental vaccine and only a 20%
chance of getting placebo.
?We are in discussions now with several companies with
vaccines in development to see if we could launch something like
this on a global trial platform,? Swaminathan said, adding that
she?s optimistic such a study may begin in the first half of
2021.
A global trial involving a wide pool of people and
countries offers several advantages, she said. Testing vaccines
in diverse ethnicities, age groups, and people with different
medical conditions makes the results more generalizable, and
when the epidemic wanes in some parts of the world it?s often
still active in others, she said.
To contact the reporter on this story:
Jason Gale in Melbourne at j.gale@bloomberg.net