Coronavirus Now: COVID-19 & Vaccine Updates for April 13

As of April 13, confirmed cases of COVID-19 now number more than 137 million around the world, including more than 31 million cases in the United States and more than 570,000 U.S. deaths. You can see a breakdown of coronavirus cases throughout the world and within the U.S. on the map and chart above.

Below you’ll find updates on the latest news about the coronavirus.

April 13 News Updates

FDA & CDC Call for Pausing Johnson & Johnson Vaccine

The FDA and CDC have called for a pause to the Johnson & Johnson vaccine while a possible rare blood clot connection is investigated, The New York Times reported. This is similar to the issue with the AstraZeneca vaccine. Both are adenovirus vector vaccines.

So far, six people in the U.S. developed the rare clotting condition — cerebral venous sinus thrombosis — and all were women between the ages of 18 and 48. One died and one is hospitalized in critical condition. About 7 million people in the U.S. have received the vaccine, but it’s not clear how many of those fall in the 18-48 demographic. The treatment for this rare blood clotting issue is different than what is typically done for clots, federal health agencies said, noting that heparin (an anticoagulant) would actually be dangerous to use in this setting, The New York Times reported.

With AstraZeneca, the condition typically developed within two weeks of vaccination.

The FDA and CDC recommended a pause in the vaccine in a joint statement on April 13. The vaccine will likely be paused at most federally run sites, and state officials will make their own decisions on the vaccines. They are pausing while they investigate the side effects and help make health care providers aware of the proper way to treat the clotting.

Johnson & Johnson said in a statement on April 9: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.”

The Australian government announced that it won’t use the Johnson & Johnson vaccine in its rollout at this time, because of the similarities to the AstraZeneca vaccine, UPI reported.

UK B117 Variant Not Linked to Increased Severity, New Study Finds, Conflicting with Previous Studies

Although the B117 UK variant is far more contagious than the original coronavirus, a new study indicates it doesn’t lead to more severe symptoms or a higher risk of death, NBC News reported. The study is published in The Lancet Infectious Diseases and reviews data from November through December, when the variant first began spreading. They did find that hospitalized patients were more likely to be under the age of 60, an ethnic minority, and were more likely to be given oxygen.

So far, there is not a scientific consensus on whether or not the strain is more severe, NBC News reported. A paper from March in Nature had reported a 61% higher risk of death with B117, and The BMJ had reported a 64% higher risk of death for people over the age of 30, with the absolute risk of death still being low.

Michigan Surge Worsens, with Hospitalization Surpassing Peak from the Fall

The coronavirus surge in Michigan is worsening, The Detroit News reported. On Monday, 3,918 adults were hospitalized, surpassing the peak hospitalization in the fall. On December 1, there were 3,884 adult hospitalizations for COVID-19 in the state. The current numbers are similar to April 2020, when the state hit a high of 3,986 hospitalizations. Many hospitals are at or near capacity.

Small Singapore Study Indicates Hospitalized People May Be at Risk of Blood Clots Even After They’re Discharged

People who recovered from COVID-19 might be at risk of developing blood clots due to an overactive immune system, according to a study at Nanyang Technological University, Channel News Asia reported. The study looked at 30 COVID-19 patients a month after they were discharged, and found signs of blood vessel damage in all 30 patients. They had elevated circulating endothelial cells and still produced high levels of cytokines.

NTU’s Assistant Professor Christine Cheung said: “This makes a strong case for the close monitoring of recovered COVID-19 patients, especially those with pre-existing cardiovascular conditions like hypertension and diabetes who have weakened blood vessels.”

Additional Vaccine Updates

GettyA  woman leaves Life Care Center of Kirkland on February 29, 2020, in Kirkland, Washington.

Timeline of Pfizer Updates (mRNA vaccine)

The first dose of the two-dose Pfizer/BioNTech vaccine delivers about 90% protection after 21 days, The Guardian reported in February. A peer-reviewed study of about 9,000 people published in Lancet in February showed that the first Pfizer dose brings 85% efficacy in preventing symptomatic disease within 15 to 28 days of the shot, The Wall Street Journal reported in mid-February.

A real-world study in Israel of the Pfizer-BioNTech vaccine shows a 94% efficacy in symptomatic infection following two doses, Reuters reported. The efficacy was the same across all age groups and co-morbidities. The study looked at 1.2 million people, and the UK variant was dominant.

Preliminary results in a preprint revealed that Pfizer’s vaccine reduces the viral load four-fold 12 to 28 days after the first dose, The Scientist reported. You can read the preprint here. One dose of the Pfizer vaccine can serve as a booster for people who already had the novel coronavirus, according to a research paper in Lancet, SciTechDaily reported.

A February study at the University of Texas revealed that the Pfizer vaccine still provides substantial protection against the SA variant, The Guardian reported. The researchers acknowledged limitations, including not having the full set of spike mutations. A newer study from early March indicated a reduced efficacy for Pfizer and Moderna against the SA variant, The Hill reported. Moderna’s was 12.4 times less effective against the SA variant and Pfizer’s was 10.3 times less effective. The study in Nature, whose accelerated preview you can read here, involved 12 participants of a Moderna Phase 1 trial and 10 participants who received the Pfizer vaccine.

While the SA variant efficacy is being debated, a new study in the New England Journal of Medicine indicates the Pfizer vaccine is likely effective against the Brazil variant, Independent reported.

Pfizer/BioNTech is working on boosters specifically against the new variants, Newsweek reported in late January. If any variants show resistance to the current vaccine, Pfizer wants to be able to produce a booster “very, very quickly.”

In late February, the FDA approved the Pfizer vaccine for normal freezer storage (temperatures of -25°C to -15°C) for up to two weeks, Time reported.

Italy researchers have proposed that people with a higher BMI may need a larger dose of the Pfizer vaccine, Independent reported in early March. The study looked at 158 females and 90 males, and saw that people with a higher BMI had a lower antibody response.

A new study from late March indicates the Pfizer vaccine is 100% effective in children ages 12 to 15, NBC News reported. The findings haven’t yet been peer-reviewed. On Facebook, Your Local Epidemiologist reported that this was very encouraging, but there are still some unanswered questions, such as final efficacy numbers with two months of data rather than one, and what exactly “well-tolerated” means in terms of safety.

Timeline of Moderna Updates

Data released in mid-December shows that Moderna’s vaccine is highly protective, The New York Times reported. The vaccine had an efficacy of 94.1% in a trial with 30,000 participants. Side effects were not dangerous but were unpleasant, including fever, headache, and fatigue. During trials, Moderna (and CanSino) both stopped giving high doses for the second dose because of the side effects, StatNews reported. Moderna’s current vaccine uses the lower dose for the second dose.

Moderna announced on January 25 that individuals who got the Moderna COVID-19 vaccine are showing neutralizing antibody activity against the UK and South Africa variants (B.1.1.7 and B.1.351.) A weaker response was observed for the South Africa variant (B.1.351), but Moderna noted that “neutralizing titer levels … are expected to be protective.” A study of the Moderna vaccine from Emory University and the University of Texas Medical Branch in early February also indicates that it generated neutralizing antibodies against variants, News Medical reported.

However, a study from early March revealed potentially less efficacy against the SA variant than previously thought, The Hill reported. Moderna’s was 12.4 times less effective against the SA variant. The study in Nature, whose accelerated preview you can read here, involved 12 participants from Moderna and 10 from Pfizer.

Moderna is working on a booster vaccine targeted to the South Africa strain, Independent reported in late February. The booster is called mRNA-1273.351.

Moderna is also studying a new COVID-19 vaccine, Reuters reported in March. This vaccine could be stored in refrigerators instead of freezers. It’s designated mRNA-1283 and is being studied as a vaccine and as a booster.

Timeline of Oxford/AstraZeneca Updates 

The Oxford-AstraZeneca vaccine (called Covidshield in India) is about 62% effective in people who got two full doses, BBC reported in late November. Another trial showed about 90% efficacy in 3,000 people who got a half-dose first and then a full dose the second time rather. The Oxford vaccine is made from an adenovirus that was modified to help human cells create the spike protein so the immune system can recognize it, Nature reported. This is similar to how Johnson & Johnson’s vaccine works and how Russia’s Sputnik V vaccine works. AstraZeneca is testing a component of Russia’s Sputnik V vaccine in its clinical trials, according to a press release.

However, this vaccine has faced a number of hurdles in recent months.

The vaccine gives mild side effects like a temperature or a headache, Reuters reported. But French health authorities recommended staggering the shot among health care workers so operations aren’t disrupted due to the intensity of the side effects.

South Africa paused its AstraZeneca/Oxford vaccine rollout in early February after an analysis revealed the vaccine only provides minimal protection against the B.1.351 South Africa variant, StatNews reported. A small study revealed that the AstraZeneca vaccine may only provide 10% protection against mild to moderate infections of the SA variant, The Guardian reported.

Then in mid-March, many countries began pausing the vaccine after concerns about blood clots. These included Germany, France, Spain, Italy, Ireland, the Netherlands, CNBC reported, along with Denmark, Norway, Iceland, Bulgaria, Luxembourg, Estonia, Lithuania, and Latvia, CNBC reported. The Norwegian Medicine Agency noted a small number of cases of a rare blood clotting situation after getting the vaccine: a combination of low platelet blood count, bleeding, and blood clots in small and large blood vessels, with similar clinical pictures seen in some European countries. The agency noted this particular condition has not been seen with other coronavirus vaccines.

WHO said it had found no links between the vaccine and blood clots, The Washington Post reported. AstraZeneca also said there was no evidence of an increased blood clot risk. On Thursday, March 18, the European Medicines Agency concluded that it didn’t increase overall blood clots, but acknowledged there was a possible connection to a rare type of clot and leaflet warnings should be updated.

Two groups of researchers in Norway and Germany believe they may have found the link between the AstraZeneca vaccine and blood clot issues, The Wall Street Journal reported in mid-March. The teams identified an antibody the vaccine creates which may trigger the rare blood clot reaction and could be treated in hospitals. The findings still need peer reviews.

Another issue cropped up later in March. AstraZeneca had announced that its vaccine was 79% effective in a U.S. trial of 30,000 volunteers, but the National Institute for Allergy and Infectious Diseases issued a statement of concern that the results were incomplete, Bloomberg reported on March 23. Fauci said there is concern that trial data was outdated and might be “misleading.” AstraZeneca responded that the numbers were based on interim analysis and they would update the numbers in a couple of days. On Facebook, Your Local Epidemiologist noted that it was “highly unusual for the Data Safety and Monitoring Board (DSMB) and a vaccine sponsor (AstraZeneca) to publicly (or privately in that matter) disagree.”

Norway announced that it will delay a decision about resuming the vaccine until April 15, Reuters reported. Denmark has also continued to pause the vaccine, deciding to extent the suspension by at least three weeks, AP News reported. On March 30, Canada suspended its use for anyone under 55, The Guardian reported. New data from Europe indicated the blood clot risk may be as high as one in 100,000. The rare blood clot typically occurs between four and 20 days after vaccination.

Germany also announced that it would stop giving the AstraZeneca vaccine to anyone under 60 unless they’re in a high-risk category for getting severe COVID-19, ABC News reported on March 30. The country has seen 31 people develop the rare clot after 2.7 million doses, most involving women between ages 20 to 63. Nine died.

The Netherlands suspended the AstraZeneca vaccine for people under 60, Reuters reported.

On April 4, the European Medicines Agency’s safety committee concluded that rare blood clots should be listed as a rare side effect of AstraZeneca’s vaccine (now renamed as Vaxzevria.) If someone who received the vaccination develops symptoms, they should seek medical help immediately. Symptoms include shortness of breath, chest pain, leg swelling, abdominal pain, persistent headaches or blurred vision, or tiny blood spots under the skin that are beyond the injection site.

Australia is officially advising people under 50 to get the Pfizer vaccine and not AstraZeneca as of early April, reported.

The EMA is also investigating capillary leak syndrome after five cases were reported following the AstraZeneca vaccine.

Timeline of Russia’s Sputnik Vaccine Updates

Russia’s Sputnik vaccine is reported to be 91.6% effective against symptomatic COVID-19 and 100% effective against moderate and severe cases, CNN reported in early February. This is reported in interim Phase 3 trials and published in The Lancet. People over age 60 showed a 91.8% efficacy. Serious reactions were rare, and most side effects included mild-flu like symptoms, pain at the injection, and low energy. The analysis hasn’t reviewed asymptomatic cases, transmission, or how long protection lasts.

Russians who receive the Sputnik V coronavirus vaccine are being asked not to drink alcohol for two months after, the New York Post reported. This is the amount of time they said it takes the vaccine to be effective and alcohol can be a strain on the body’s immune response, the experts said.

In mid-February, the first 100,000 doses of the Sputnik vaccine arrived in Venezuela, Yahoo News reported. On February 23, AP reported that Mexico received its first shipment of the Sputnik vaccine: 200,000 doses.

Fauci said in late March that data on Russia’s Sputnik V Vaccine indicates it’s “quite effective” and “looks pretty good,” Bloomberg reported. He had previously said he was skeptical of the vaccine when Russia approved it before Phase 3 trials.

A committee of experts has recommended Sputnik V’s use in India, NDTV reported on April 12. If approved, this would make it India’s third vaccine, alongside Covishield (AstraZeneca’s vaccine) and Covaxin. It still requires approval by the Drug Controller General of India before it can be used.

Timeline of Novavax Updates

Novavax announced that in its Phase 1 vaccine trial for NVX-CoV2373, antibodies were induced in 100% of participants, The Motley Fool reported. The vaccine had mild side effects, typically worse with the second dose. On November 9, it was granted fast-track designation by the FDA and is in late-phase clinical development. This is not an mRNA vaccine, ScienceMag reported. Instead, Novavax is using a baculovirus to insert a gene for the spike protein, harvesting the spike proteins and using that in an adjuvant.

In mid-February, FT reported that Novavax was about to finish its U.S. trial of the vaccine in record time, having enrolled 30,000 participants since beginning the trial in late December. A UK trial of the two-shot vaccine found it 85.6% effective against B.1.1.7 and 95.6% effective against the original variant.

Production of the vaccine is underway in Billingham as of late March, along with some areas in the United States, TessideLive reported. The UK has ordered 60 million doses, but the vaccine hasn’t yet been approved by the MHRA.

Timeline of Inovio Updates

Inovio is working on a vaccine called the INO-4800 DNA vaccine. Inovio announced positive results from two Phase I clinical trials in early July. The Phase 1 trial was expanded to include older participants in June and July. This is a nucleic-based vaccine that will be stable at room temperature for more than a year and doesn’t need to be frozen.

On January 4, Inovio said it expected to begin a late-stage study of its vaccine in the U.S. in the second quarter of 2021 after finishing mid-stage trials in March, Reuters reported. The vaccine has three mid-stage trials, one in the U.S., one in China with Advaccinek, and one in South Korea. The U.S. Phase III trial had been delayed as the FDA requested more information on the delivery device.

On February 12, Inovio shares traded higher, Seeking Alpha reported. Analyst Hartaj Singh believed Inovio’s vaccine showed promise, noting: “We believe the overall DNA platform by INO should not be overlooked.”

Timeline of Johnson & Johnson Updates

Johnson & Johnson has received emergency use authorization for its vaccine. Data related to Johnson & Johnson’s vaccine shows 66% overall effectiveness: 57% in South Africa (rising to 64% after about a month), 66% in Latin America, and 72% in the United States, CNBC reported. The vaccine group reported no deaths, while the placebo group reported seven deaths. People ages 60 and older with comorbidities had a lower efficacy rate of about 42.3%. You can read the 62-page FDA briefing document from Johnson & Johnson here.

Merck and Johnson & Johnson, two companies that are historically competitors, will work together to increase vaccine production, CNN reported.

Following approval in the United States, Canada has now approved Johnson & Johnson’s vaccine, CBC reported.

Johnson & Johnson is working on new COVID-19 vaccines that would be effective against variants, Reuters reported in mid-March. This second-gen vaccine would be aimed at the SA variant and might be in the form of a booster.

EMA announced on April 9 that it was investigating if Johnson & Johnson’s vaccine might have any correlation with rare thromboembolic events. Four serious cases of the unusual blood clots were reported: one case from a clinical trial and three during a vaccine rollout in the U.S. One case was fatal. The EU has authorized the vaccine but has not yet started rolling it out. As of April 4, there were more than 4 million doses administered, NPR reported.

EMA noted: “These reports point to a ‘safety signal’, but it is currently not clear whether there is a causal association between vaccination with COVID-19 Vaccine Janssen and these conditions. PRAC is investigating these cases and will decide whether regulatory action may be necessary, which usually consists of an update to the product information.”

Timeline of CureVac updates

On February 12, EMA began a rolling review of CureVac’s vaccine, CVnCoV, EMA reported. CureVac is conducting clinical trials on safety, immune response, and effectiveness. CureVac utilizes the mRNA vaccination method.

On February 25, CureVac announced that preliminary animal trials showed it was effective against UK and SA variants, Reuters reported.

On March 4, CureVac and Novartis signed a manufacturing agreement for the second quarter of 2021, with the hope of having 50 million doses available by the end of 2021 and 200 million in 2022. Manufacturing would take place in Austria.

CureVac is now expanding late-stage clinical trials as of late March, BioPharma reported. The trials will look at efficacy against UK, SA, and Brazil variants. Phase 1 data showed strong antibody responses and T cell activation.

Timeline of Sanofi and GlaxoSmithKline Updates

Sanofi and GlaxoSmithKline vaccine early trials were disappointing, The New York Times reported in mid-December. The vaccines didn’t produce a good immune response in older participants, although they did in people under 50.

Timeline of China/Sinovac’s CoronaVac Vaccine Updates

A new study calls into doubt whether Sinovac’s CoronaVac vaccine will trigger enough protection against the Brazil variant, Reuters reported. This was based on plasma samples from eight people, which didn’t effectively neutralize the variant. CoronaVac is most commonly used in China, Brazil, Turkey, and Indonesia.

Meanwhile, Turkish trials showed China’s Sinovac vaccine was 83.5% effective, and 100% effective in preventing hospitalization, Bloomberg reported. Officials in Brazil had said it was 50.38% effective in preventing cases.

Timeline of China’s CanSino Biologics’ Inhaled Vaccine Updates

China’s CanSino Biologics has obtained approval to start clinical trials of an inhaled COVID-19 vaccine using an Adenovirus Type 5 vector, Global Times reported in late March. The vaccine is the same as the already approved single-dose vaccine, only using an “atomization inhalation device.”

Timeline of Covaxin Updates

Covaxin, a vaccine from India created by Bharat Biotech International and the Indian Council of Medical Research, showed an efficacy of 81% after two doses in early Phase 3 data, but whether this applied to mild symptoms or severe cases isn’t known, Bloomberg reported. This data was based on 36 cases of COVID-19 in a placebo group versus seven cases in a vaccinated group. The vaccine came under criticism when it was rolled out in India before Phase 3 trial data was available.

On March 4, Zimbabwe announced that it had approved the vaccine for use, making it the first country in Africa to authorize the vaccine.

Timeline of Zoetis Animal Vaccine Updates

San Diego Zoo vaccinated nine great apes (four orangutans and five bonobos) using an experimental COVID-19 vaccine, The San Diego Union-Tribune reported. They’re planning to vaccinate three more bonobos and a gorilla. The apes were given two doses in January and February, spaced by three weeks. They voluntarily sat down for the injections, which weren’t forced. No visible side effects have been noted, except a few rubbed their head or the injection site.

Zoetis, which was once part of Pfizer, is developing the COVID-19 vaccine for animals. It delivers a piece of the surface protein, similar to how Novavax works. The doses aren’t authorized for people.

The vaccine will soon be trialed in a formulation developed for minks, The Guardian reported in late March. A vaccine among minks might help slow down the emergence of variants that could infect the human population.

Timeline of Oravax Medical’s Oral Vaccine Updates

Oramed Pharmaceuticals, an Israeli-American pharmaceutical company, is working with India’s Premas Biotech to develop a vaccine by a new company called Oravax Medical. This would be an oral vaccine that could be taken at home, The Jerusalem Post reported in late March. Phase 1 trial data could be available within three months. The vaccine targets three structural proteins rather than one spike protein, and the company believes it may be more resistant to variants.

ImmunityBio Oral Vaccine Updates

At Chan Soon-Shiong Research Institute in El Segundo, California, researchers from ImmunityBio are testing an oral COVID-19 vaccine, CBS News reported in early April. It’s being tested on healthy volunteers using four approaches, including some people getting both the pill and a vaccine shot. The pill targets creating T cells that react to a globe in the middle of the virus that’s less prone to mutation, while current vaccines create antibodies to the spike protein. The trial is available to people who are 55 or younger, haven’t had COVID, and aren’t pregnant.

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